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Last update 07 May 2026

Vinorelbine Tartrate

Last update 07 May 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

5'-Noranhydrovinblastine, NVB, Vinorelbine

+ [19]

Target

alpha-tubulin x β-tubulin

Action

inhibitors

Mechanism

alpha-tubulin inhibitors(Tubulin alpha inhibitors), β-tubulin inhibitors(tubulin beta class I inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesSkin and Musculoskeletal Diseases+ [1]

Active Indication

Non-Small Cell Lung CancerBreast CancerAdvanced Lung Non-Small Cell Carcinoma+ [5]

Inactive Indication

Advanced cancerBone metastasesCastration-Resistant Prostatic Cancer+ [10]

Originator Organization

Pierre Fabre SA

Active Organization

Kyowa Kirin Co., Ltd.

Pierre Fabre SA

Mirati Therapeutics, Inc.

+ [5]

Inactive Organization

Pierre Fabre Pharma GmbH

GSK Plc

Amgen, Inc.

+ [7]

License Organization

Biotoscana Investments SA

Pierre Fabre (Shanghai) Medical Technology Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1989),

Breast Cancer

RegulationOrphan Drug (European Union)

Structure/Sequence

Molecular FormulaC49H60N4O14

InChIKeyUUHYRRXICWUZHW-RPZOAHRESA-N

CAS Registry125317-39-7

538

Clinical Trials associated with Vinorelbine Tartrate

NCT07466316

/ Not yet recruitingPhase 3IIT

A Randomized Phase 3 Study to Compare VAC (Higher Cyclophosphamide Dose and Intensity) Versus VAC/VI (Lower Cyclophosphamide Dose and Intensity) Plus Maintenance Therapy in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma

This phase III trial compares higher dose chemotherapy, with vincristine, dactinomycin and cyclophosphamide, over a shorter amount of time to lower dose chemotherapy plus maintenance, with vincristine, dactinomycin, cyclophosphamide, irinotecan and vinorelbine, over a longer amount of time, along with standard of care surgery and radiation, in patients with newly diagnosed intermediate risk rhabdomyosarcoma. Vincristine and vinorelbine are in a class of medications called vinca alkaloids. They work by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. It is not yet known if the higher dose chemotherapy over a shorter amount of time or the lower dose chemotherapy with maintenance over a longer amount of time is more effective in the treatment of patient with newly diagnosed, intermediate risk rhabdomyosarcoma.

Start Date22 Jun 2026

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

NCT07021989

/ Not yet recruitingPhase 2IIT

Pembrolizumab and GVD With ctDNA-guided Consolidation in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma: A Multicenter Phase 2 Study of the University of California Hematologic Malignancies Consortium

This is a single arm, open-label, multicenter, phase II study of pembrolizumab (pembro), gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) with response-adapted consolidation. This study will investigate using circulating tumor DNA (ctDNA) at pre-determined time points using Foresight CLARITY LDT, an ultra-sensitive liquid biopsy platform that detects Minimal residual disease (MRD) in patients with B-cell lymphomas using the phased variant enrichment and sequencing technology (PhasEDq) to determine response to study interventions.

Start Date01 May 2026

Sponsor / Collaborator

The University of California, San Francisco

[+3]

ChiCTR2600121540

/ Not yet recruitingPhase 2IIT

Almonertinib Plus Oral Vinorelbine as First-line Treatment for EGFR-sensitive Mutation-positive Advanced Non-small Cell Lung Cancer with Performance Status 2-4: A Prospective, Multicenter, Single-arm, Phase II Clinical Study

Start Date07 Apr 2026

Sponsor / Collaborator-

100 Clinical Results associated with Vinorelbine Tartrate

100 Translational Medicine associated with Vinorelbine Tartrate

100 Patents (Medical) associated with Vinorelbine Tartrate

4,210

Literatures (Medical) associated with Vinorelbine Tartrate

01 Mar 2026·Clinical Case Reports

Case Report of Acute Severe Hyponatremia Induced by Desmopressin Administration During Chemotherapy

Article

Author: Takashi Yoshioka ; Koutaro Ono ; Ayako Tsuboya ; Aya Yoshihara ; Shuichi Nawata ; Shoichi Mori ; Shugo Uematsu

ABSTRACT:

Patients undergoing chemotherapy are prone to developing hyponatremia due to insufficient oral intake because of nausea and vomiting, administration of large volumes of intravenous fluids, syndrome of inappropriate antidiuretic hormone secretion induced by chemotherapeutic agents, adrenal insufficiency, and drug interactions. Severe hyponatremia during chemotherapy interferes with continuation of cancer treatment. In addition, it may be difficult to distinguish hyponatremia from chemotherapy‐related adverse effects because of symptom similarity. This report presented a case of desmopressin‐induced severe hyponatremia during chemotherapy and discussed the appropriateness of discontinuing desmopressin administration. A 70‐year‐old male was hospitalized for postoperative adjuvant chemotherapy with cisplatin and vinorelbine for a pathological stage IIB adenocarcinoma of the right lower lung lobes. The patient had been taking oral desmopressin (25 μg daily) for 4 years to treat nocturnal polyuria. Desmopressin was discontinued on day 1 of chemotherapy because of a contraindicated combination with dexamethasone, which was administered as an antiemetic. Desmopressin was resumed on day 6, but was followed by Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 nausea, anorexia, and CTCAE Grade 4 hyponatremia (serum sodium concentration of 119 mEq/L) on day 7. Severe hyponatremia progressed following the resumption of desmopressin treatment. Desmopressin was not reintroduced thereafter, and subsequent chemotherapy cycles were continued without recurrence of hyponatremia. The patient completed all four planned adjuvant chemotherapy cycles. This case study highlighted the importance of carefully evaluating the necessity of continuing desmopressin administration and considering its discontinuation during chemotherapy to prevent the onset of hyponatremia.

01 Mar 2026·AGING CELL

Altered Cytokine‐Induced STAT3 and STAT5 Activation of Peripheral T Follicular Helper Cells Contributes to Vaccine‐Non‐Responsiveness in Aging and HIV

Article

Author: Davis, Sheldon ; Pallikkuth, Suresh ; Pahwa, Savita ; Singh, Prabhsimran ; Kupritz, Jonah

ABSTRACT:

Previous studies from our lab identified functional defects in antigen‐specific peripheral T follicular helper cells (pTfh), characterized by low IL‐21 and high IL‐2 production, contributing to non‐responsiveness to the influenza vaccine in both aging and HIV. This study investigated how IL‐21‐induced STAT3 and IL‐2‐induced STAT5 activation in pTfh cells affects vaccine responses in aging people with HIV (PWH) and those without HIV (PWoH). Ninety participants, including young (Y, ≤ 40 years) and old (O, ≥ 65 years) PWoH (YPWoH, n = 23; OPWoH, n = 25) and virally suppressed PWH (YPWH, n = 19; OPWH, n = 23), received the seasonal quadrivalent influenza vaccine. Samples were collected at pre‐vaccination (day 0) and at days 14 and 28 post‐vaccination. Participants were classified as vaccine responders (VR) or non‐responders (VNR) based on serum antibody titers against vaccine antigens using the hemagglutination inhibition assay. Phosphoflow cytometry was performed on pre‐vaccination PBMCs stimulated with IL‐21 or IL‐2, and high‐dimensional analysis was performed using OMIQ software. Peripheral Tfh cells of young individuals showed greater IL‐21‐induced STAT3, reduced IL‐2‐induced STAT5 activity, and a reduced frequency of IL‐2R+ pTfh cells compared to older individuals. IL‐21‐induced STAT3 in naïve CD4+ T cells in young participants correlated with the frequency of pTfh cells. Among VNR, IL‐2‐induced STAT5 in pTfh cells inversely correlated with day 28 vaccine titers. Our findings emphasize the essential role of IL‐21 and IL‐2‐induced STAT signaling in orchestrating the immune response to vaccination. As individuals age, IL‐2‐induced STAT5 signaling in pTfh increases, potentially hindering Tfh cell differentiation and function, which may result in weaker vaccine responses.

01 Mar 2026·JOURNAL OF PEDIATRIC HEMATOLOGY ONCOLOGY

Refractory/Relapsed Hodgkin Lymphoma in Cartilage Hair Hypoplasia–Anauxetic Dysplasia Spectrum: Long-term HSCT-free Remission in 2 Pediatric Siblings

Article

Author: Fadoo, Zehra ; Bukhari, Syed Ibrahim ; Yazdani, Sahr

Cartilage hair hypoplasia–anauxetic dysplasia (CHH-AD) spectrum disorders are rare skeletal dysplasias caused by pathogenic variants in RMRP, associated with immune dysfunction and cancer predisposition. While non-Hodgkin lymphoma is more commonly seen, Hodgkin lymphoma (HL) is rarely reported, and its management in this setting remains unclear. We describe 2 siblings with genetically confirmed CHH-AD who developed relapsed/refractory EBV-positive classic HL. Both presented with short stature, atopy, recurrent infections, and elevated IgE. The brother was diagnosed with stage IV disease, and the sister with stage IIB. Despite receiving frontline chemotherapy, both relapsed within a year. Salvage therapy with gemcitabine/vinorelbine induced metabolic responses, followed by radiotherapy and consolidation with brentuximab vedotin. Autologous transplant was considered but declined by the family due to perceived risks. At 30 months follow-up, both remain in complete remission. Genetic testing confirmed a shared homozygous pathogenic RMRP variant. These cases expand the oncologic spectrum of CHH-AD to include HL, highlight the risk of aggressive disease and early relapse, and demonstrate that durable remission may be achieved without transplantation when consolidation with targeted therapy is feasible. Early recognition of CHH-AD features in HL patients may allow risk-adapted therapy and informed genetic counseling.

News (Medical) associated with Vinorelbine Tartrate

02 Oct 2025

·www.globenewswire.com

HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2025

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Congress 2025, taking place on October 17-21, 2025 in Berlin, Germany. Results from the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma will be presented in a Mini Oral session. Additionally, further analyses of the fruquintinib FRUSICA-1 study in endometrial cancer and the savolitinib SACHI and SAVANNAH studies in non-small cell lung cancer will be presented during the poster sessions. Details of the presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): results from phase 3 part of a randomized, open-label, active-controlled phase 2/3 study (FRUSICA-2)Zhenhua Liu(Chengdu, China)2592MOMini Oral Session 1: GU tumours, renal & urothelialFriday, Oct 17, 2025Karlsruhe Auditorium - Hall 5.216:00 - 17:30 CESTA Fruquintinib Expanded Access Program (EAP) to Provide Treatment for Patients With Metastatic Colorectal Cancer (mCRC)Stefan Kasper-Virchow (Essen, Germany)794P Poster Session:Colorectal cancerFruquintinib plus tislelizumab in microsatellite stable metastatic colorectal cancer: Results from a phase 1b/2 studyN. Arvind Dasari (Houston, USA)799PPoster Session:Colorectal cancerA novel artificial intelligence (AI) imaging biomarker of tumor vascularity and heterogeneity radiomics to predict survival benefit of fruquintinib vs placebo in metastatic colorectal cancer (mCRC)Sara Lonardi (Padua, Italy)804PPoster Session:Colorectal cancerSafety and tolerability of fruquintinib: Pooled analysis of three placebo-controlled studies in patients with metastatic colorectal cancerCathy Eng (Nashville, USA)811PPoster Session:Colorectal cancerAssociation between Metabolic Syndrome (MetS) and clinical outcomes of Fruquintinib plus Sintilimab in Previously Treated Advanced Endometrial Cancer (EMC) Patients with pMMR Status: results from FRUSICA-1 studyDanbo Wang (Shenyang, China)1230eP Poster Session:Gynaecological CancerctDNA analysis in phase 3 SACHI trial: savolitinib (savo) plus osimertinib (osi) versus chemotherapy (chemo) in MET-amplified (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI)Yongfeng Yu (Shanghai, China)1954P Poster Session: NSCLC, metastaticSAVANNAH: Safety and tolerability of osimertinib (osi) + savolitinib (savo) in EGFRm advanced NSCLC with MET overexpression and/or amplification (OverExp/Amp) following disease progression on osiQuincy Siu-chung Chu (Edmonton, Canada)1955P Poster Session: NSCLC, metastaticMET testing and treatment (tx) sequencing after progression on first line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): interim analysis of a global real world (rw) studyJulia Rotow (Boston, USA)1956P Poster Session: NSCLC, metastatic INVESTIGATOR-INITIATED STUDIES Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated surgical and survival results from the single-arm, phase 2 clinical trialFei Ma (Zhengzhou, China)2159P Poster Session: Oesophagogastric cancerFruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, Phase II StudyWangjun Liao (Guangzhou, China)898ePE-poster Session:Colorectal cancerThe efficacy and safety of surufatinib combined with chemotherapy in the first-line treatment of advanced periampullary carcinoma: a single arm, prospective, exploratory clinical studyQianqian Wang (Nanjing, China)929P Poster Session: Developmental therapeuticsSurufatinib-Based Late-Line Therapy Outcomes in Recurrent Metastatic NSCLC: Monotherapy and Vinorelbine Combination RegimensYanfang Zheng(Guangzhou, China)1884PPoster Session:NSCLC, metastaticSurufatinib combined with Toripalimab, Pemetrexed, and Platinum in Advanced Non-Squamous Non-Small Cell Lung Cancer (nsg-NSCLC): Final Phase II Results from a Single-Center TrialWenfeng Fang/ Li Zhang(Guangzhou, China)1887PPoster Session: NSCLC, metastaticEfficacy/safety and preliminary scRNA-seq results of surufatinib plus gemcitabine and nab-paclitaxel as neoadjuvant therapy in resectable and borderline resectable pancreatic cancerSong Gao/ Jihui Hao(Tianjin, China)2236PPoster Session: Pancreatic cancerEfficacy and Safety of Surufatinib in Patients with Advanced Soft Tissue Sarcoma After Failure of Anthracycline Chemotherapy and Prior Effective Antiangiogenic Therapy: A Single-Arm, Prospective, Exploratory Phase II StudyXiaowei Zhang/ Zhiguo Luo (Shanghai, China)2716PPoster Session: Sarcoma About Fruquintinib Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®. About Savolitinib Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®. About Surufatinib Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib and savolitinib, the further clinical development for fruquintinib, surufatinib and savolitinib, its expectations as to whether any studies on fruquintinib, surufatinib and savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib and savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib and savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as sintilimab and toripalimab as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

Phase 2ImmunotherapyClinical ResultPhase 3Drug Approval

28 Apr 2025

·www.businesswire.com

Delcath Systems Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of HEPZATO™ in Liver-Dominant Metastatic Breast Cancer

QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day review of the Company's Investigational New Drug (IND) application for a Phase 2 clinical trial evaluating HEPZATO™ in combination with standard of care (SOC) for liver-dominant metastatic breast cancer (mBC). With the FDA's review complete, Delcath is now cleared to initiate patient enrollment in the U.S. The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with SOC versus SOC alone in patients with liver-dominant HER2-negative mBC following the failure of previous treatments. The SOC options will be the physician’s choice of eribulin, vinorelbine or capecitabine. Approximately 90 patients will be enrolled in this randomized, controlled trial. The study will take place at more than 20 sites across the United States and Europe, with patient enrollment expected to begin in the fourth quarter of 2025. The trial’s primary endpoint, hepatic progression-free survival, is anticipated to be announced by the end of 2028, while results for overall survival, a secondary endpoint, are expected in 2029. Company management estimates that approximately 7,000 patients annually in the United States are affected by HER2-negative metastatic breast cancer with liver metastases and are candidates for third line treatment. This population includes patients with a significant burden of liver metastases, which are likely to be the primary cause of mortality. By focusing on this demographic, Delcath intends to offer a novel therapeutic option to those patients with limited treatment alternatives. “This randomized Phase 2 trial marks an important milestone as we expand the clinical investigation of HEPZATO into patients with liver-dominant metastatic breast cancer,” said Gerard Michel, Chief Executive Officer of Delcath Systems, Inc. “We are excited to bring new hope to patient populations in indications beyond metastatic uveal melanoma and to further demonstrate the potential of HEPZATO to address unmet needs in oncology. This study underscores our commitment to broadening the applications of HEPZATO and the underlying hepatic delivery system, positioning us as a platform technology that can offer directed treatment options for a variety of liver-dominant cancers.” About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver. Forward-Looking Statements This release contains forward-looking statements, including statements regarding the expected timeline for trial enrollment and data readouts, which are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, delays in regulatory review, site activation, patient enrollment, or unforeseen clinical trial results. For a detailed discussion of these and other risks, please refer to Delcath’s filings with the SEC.

Phase 2INDDrug Approval

08 Apr 2025

·pipelinereview.com

DATROWAY® Approved in the EU for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

TOKYO, Japan & MUNICH, Germany I April 08, 2025 I DATROWAY ® (datopotamab deruxtecan) has been approved in the European Union (EU) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). The approval by the European Commission follows the positive opinion of the Committee for Medical Products for Human Use of the European Medicines Agency and is based on results from the TROPION-Breast01 phase 3 trial. In TROPION-Breast01, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 months (95% CI: 4.9-6.8) in the chemotherapy arm. The final overall survival (OS) results of the trial did not achieve statistical significance (median OS of 18.6 months in the DATROWAY arm versus 18.3 months in the chemotherapy arm [HR 1.01; 95% CI: 0.83-1.22]) and may have been affected by subsequent ADC treatment. “With the majority of breast cancer cases historically considered HR positive, HER2 negative, additional treatment options are needed to improve outcomes for patients with metastatic disease that continues to progress following endocrine-based therapy and initial chemotherapy,” said Barbara Pistilli, MD, Head of the Breast Cancer Unit in the Medical Oncology Department of Gustave Roussy Cancer Center, Villejuif, France. “The approval of DATROWAY in the EU will provide these patients with a new treatment option that can help slow the progression of this disease.” “Treating metastatic HR positive, HER2 negative breast cancer presents challenges, particularly treatment resistance and disease progression that occur following endocrine-based therapy and initial chemotherapy,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “DATROWAY represents the second antibody drug conjugate approved for breast cancer based on Daiichi Sankyo’s DXd technology and the third medicine to be approved in the EU from our oncology pipeline, underscoring our commitment to creating new medicines for patients with cancer.” “Though the HR positive breast cancer treatment landscape has evolved in the last several years, disease progression on front-line therapies remains a common and complex challenge for patients with metastatic disease,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “With today’s approval of DATROWAY, patients in the EU with HR positive, HER2 negative breast cancer now have a new and needed alternative to conventional chemotherapy.” Grade 3 or higher adverse events from a pooled safety analysis of two clinical studies, including 443 patients who received DATROWAY (6 mg/kg) for a median duration of 6.2 months (range: 0.7-28.5), were stomatitis (7.9%), fatigue (4.3%), anemia (3.2%), AST increased (2.7%), vomiting (1.6%), ALT increased (1.6%), nausea (1.4%), urinary tract infection (1.4%), COVID-19 (1.1%), decreased appetite (1.1%), neutropenia (1.1%) and pneumonia (1.1%). Grade 5 adverse events occurred in 0.7% of patients due to interstitial lung disease/pneumonitis, dyspnea and sepsis. About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, DoR, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology and OS results were presented at a Virtual Plenary session hosted by the European Society for Medical Oncology in February 2025. TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov . About Hormone Receptor Positive, HER2 Negative Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally. 1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually. 2 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 3 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-). 3 Endocrine therapy is widely given consecutively in the early lines of treatment for metastatic HR positive breast cancer. 4 However, after initial treatment, further efficacy from endocrine therapy is often limited. 4 About DATROWAY DATROWAY (datopotamab deruxtecan) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results of the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU ® in March 2019 and DATROWAY in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . SOURCE: Daiichi Sankyo

Phase 3Clinical ResultDrug ApprovalADCLicense out/in

100 Deals associated with Vinorelbine Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
D01935	Vinorelbine Tartrate	L01CA04	DB00361

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	United States	Pierre Fabre Médicament SAS	23 Dec 1994
Breast Cancer	-	Pierre Fabre SA	01 Jan 1989

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 3	France	Pierre Fabre Medicament Information	24 Feb 2016
Hormone receptor positive HER2 negative breast cancer	Phase 3	France	Pierre Fabre Medicament Information	24 Feb 2016
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Germany	Pierre Fabre Medicament Information	01 Apr 2005
Non-small cell lung cancer stage III	Phase 3	Germany	Pierre Fabre Medicament Information	01 Apr 2005
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	United States	GSK Plc	01 Aug 2001
Neoplasms	Phase 2	China	-	19 Jun 2017
Advanced breast cancer	Phase 2	Italy	Pierre Fabre SA	29 Jul 2011
Bone metastases	Phase 2	Austria	Pierre Fabre Medicament Information	06 May 2010
Hormone receptor positive breast cancer	Phase 2	Austria	Pierre Fabre Medicament Information	06 May 2010
Disease Progression	Phase 2	Argentina	GSK Plc	01 Nov 2009

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2500111096 (ESMO_ELCC2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR-mutated	131	oral vinorelbine + furmonertinib (TNM M1c2 disease)	hzuvrhhpgn(nvadzpffdd) = ogpqdlyxxd ntmilnyqje (gqyykkaowb )	Positive	25 Mar 2026
ChiCTR2500111096 (ESMO_ELCC2026)	Phase 2		131	vinorelbine + furmonertinib (PD-L1 tumor proportion score ≥25%)	pnqumchgmj(rwxtgojywr) = aubrilhdhu xhozzlcwlh (vpkjnavedd )	Positive	25 Mar 2026
ASH2025	Not Applicable	Refractory Classic Hodgkin Lymphoma	8	BeGEV regimen	actxiwjfps(gcvqmhrrlo) = The most frequent BeGEV-related adverse event was grade 1-2 neutropenia (occurring in 2/8 patients, 25.0%). No bendamustine-related toxicities such as alopecia or peripheral neuropathy were observed. obznxxmwul (rtzjjiftcl ) View more	Positive	06 Dec 2025
NCT03618550 (ASH2025)	Phase 2	Refractory Hodgkin Lymphoma Second line	39	Pembrolizumab 200mg IVVinorelbine 20mg/m² IV + Pembrolizumab 200mg IVVinorelbine 20mg/m²m² IV + Pembrolizumab 200mg IVVinorelbine 20mg/m² + Pembrolizumab 200mg IVVinorelbine 20mg/m²in 15mg/m² IV	lpteewrnuv(aghfsdzvdr) = zstqnlauxf rpddytexbk (jtbcbtxmck ) View more	Positive	06 Dec 2025
ChiCTR2300074586 (ESMO_ASIA2025)	Phase 2	Non-Small Cell Lung Cancer First line	48	Metronomic oral vinorelbine + PD-1 inhibitors	fuivbvhylg(cqdgcgvvvt) = wnyfihvpza zppfejscnp (xhfhwvilib ) View more	Positive	05 Dec 2025
ESMO2025	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	304	metronomic oral vinorelbine (post-immunotherapy + second-line)	kjzipnowck(eqhqfpaskf) = qzcxqefppb glgetxcmin (rlaitajoty ) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	304	metronomic oral vinorelbine (post-EGFR TKIs + second-line)	kjzipnowck(eqhqfpaskf) = scqjjlfztv glgetxcmin (rlaitajoty ) View more	Positive	17 Oct 2025
NATCH-ICI (ESMO2025)	Phase 3	Non-Small Cell Lung Cancer Neoadjuvant	330	paclitaxel/pemetrexednivolumabcarboplatin + paclitaxel/pemetrexednivolumabcarboplatin + paclitaxel/pemetrexednivolumabcarboplatinpemetrexed	gnzilgjuab(vegxgapyxy) = bbfnmxlrnd iqeohfhkcc (dnqyjndtrv )	Superior	17 Oct 2025
EANO2025	Not Applicable	Diffuse midline glioma, point mutation K27M in histone H3 First line H3-K27 altered	105	Nimotuzumab and Vinorelbine	hdfrgzxkgf(gjjcyydoru) = amfbdzksqz fdigqygthk (zmzidomwno, 2.5 - 19.6) View more	Positive	16 Oct 2025
EANO2025	Not Applicable		105	Temozolomide	hdfrgzxkgf(gjjcyydoru) = kgsiljncle fdigqygthk (zmzidomwno, 1.9 - 93) View more	Positive	16 Oct 2025
NCT03518606 (MOVIE, Pubmed \| Breast)	Phase 2	Advanced breast cancer ER Negative \| PR Negative \| HER2 Negative	30	Tremelimumab plus Durvalumab combined to metronomic oral Vinorelbine	qbqbrnjrvy(puhbagdosu) = xsixtxggci gszxalpeqq (oqpvdnmhpg, 5.5 - 29.8) View more	Negative	01 Oct 2025
ChiCTR2300074586 (ASCO2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line PD-L1 expression	37	PD-1 inhibitors plus metronomic oral vinorelbine (mOV)	dfztshcgtv(anoljedvzl) = mbytpptlmb ghhafjqvem (eyhsrcwxbz, 1.0 - 20.9) View more	Positive	30 May 2025
ESMO_BC2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2+	58	Trastuzumab and Pertuzumab with Taxanes	yjkcozvmot(peecixwrtb) = qkrbvfnluu tjnmwgffht (gbjqogxjmu ) View more	-	14 May 2025

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