RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China)

Structure/Sequence

Molecular FormulaC21H19FN6O2

InChIKeyIIXWYSCJSQVBQM-LLVKDONJSA-N

CAS Registry1454846-35-5

Clinical Trials associated with Lorlatinib

NCT06333899

/ Not yet recruitingEarly Phase 1IIT

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.

Start Date01 Jul 2025

Sponsor / Collaborator

Nationwide Children's Hospital

[+1]

NCT06678555

/ Not yet recruitingNot Applicable

A Retrospective Study to Evaluate the Real-World Effectiveness of Lorlatinib Among ROS1-Positive NSCLC Patients

The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.
This study is seeking participants who:
* have lung cancer that could not be controlled.
* have a type of gene called a ROS proto-oncogene 1. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have received at least 1 treatment before.
All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take lorlatinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

Start Date30 May 2025

Sponsor / Collaborator

Pfizer Inc.

NCT06893354

/ Not yet recruitingPhase 4IIT

Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics

This is an open-label, randomized, single-center study. This translational study aims to explore tumor microenvironment remodelling after induction therapy lorlatinib and identify mechanisms of disease persistence and potential primary resistance mechanisms of lorlatinib as induction therapy treatment in surgically resectable ALK-rearranged NSCLC by single-cell RNA sequencing (scRNA-seq) and Spatial transcriptomics.

Start Date10 May 2025

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou Medical University

100 Clinical Results associated with Lorlatinib

100 Translational Medicine associated with Lorlatinib

100 Patents (Medical) associated with Lorlatinib

920

Literatures (Medical) associated with Lorlatinib

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Intrathecal pemetrexed for leptomeningeal metastases in a patient with ALK-rearranged lung adenocarcinoma: a case report

Article

Author: Wakelee, Heather ; Gezelius, Emelie ; Planck, Maria ; Nagpal, Seema ; Hazem, Bassam

Abstract:

Progressive leptomeningeal metastases (LM) are associated with intractable neurological symptoms and a poor prognosis, and effective treatment options are limited. Intrathecal (IT) pemetrexed has been shown to confer clinical benefit in lung adenocarcinoma, yet our understanding of the efficacy and safety of the treatment is limited. We report a patient with a long-standing history of leptomeningeal disease due to ALK-positive adenocarcinoma of the lung, previously controlled by increased doses of lorlatinib (125 mg/day). Rapid LM progression prompted the start of IT pemetrexed, after which the patient experienced immediate clinical improvement. The case provides additional support that IT pemetrexed can offer symptomatic relief and may be considered as a treatment option in advanced LM. Furthermore, the case illustrates that an increased dose of lorlatinib may efficiently control LM in patients with ALK-rearranged NSCLC, following progression on standard lorlatinib dosage.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Advancements in neuroblastoma treatment: FDA-approved drugs and role of phytochemicals

Review

Author: Chandel, Shivani ; Kumar, Rajneesh ; Singh, Rajveer ; Rajpoot, Satyapal

Neuroblastoma (NB) is a solid Pediatric tumor that forms in immature nerve cells. Commonly affecting the adrenal glands, spinal cord, or neck. This cancer is prevalent in children under five years old and accounts for over 15% of cancer-related deaths in this age group. Low-risk tumors can be treated surgically, intermediate-risk tumors require surgery and chemotherapy, and radiation therapy for high-risk Advancements in treatment through FDA-approved drugs and plant-derived compounds. FDA-approved drugs like Entrectinib, Dinutuximab, Unitaxin, Doxorubicin, Hydrochloride, Lorlatinib, and Crizotinib are pivotal in treating neuroblastoma. These agents inhibit pathways such as TrkA/B/C, ROS, and ALK, and the GD2 antigen. In addition to these therapies, phytochemicals have emerged as promising anticancer agents. Compounds such as quercetin, rutin, chalcone, gedunine, lycorine, withaferin A, and resveratrol have anti-cancer properties in preclinical models, targeting tumor growth and apoptosis pathways. These are improving the prevention of tumor growth through cross-reactions. Additional plant extracts have exhibited activity against neuroblastoma. This review highlights the synergistic potential of FDA-approved drugs and plant-derived phytoconstituents in improving neuroblastoma treatment outcomes.

01 Sep 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Progression and expansion of ALK inhibitors against NSCLC: A dual target approach

Review

Author: Gupta, Ghanshyam Das ; Kumari, Shreya ; Akhter, Mymoona ; Sharma, Kalicharan

ALK gene is a member of the tyrosine kinase receptor family found on chromosome 2 (2p23) that plays an important role in the progression of the non-small cell lung cancer (NSCLC). Since the ALK inhibitors such as Crizotinib, Ceritinib, Brigatinib, Alectinib and Lorlatinib, was endorsed for the treatment of advanced NSCLC linked to ALK gene rearrangement. But eventually, patients become resistant to the medication, which will result in treatment failure. However, treatment for NSCLC could be greatly advanced by the development of dual inhibitors that target ALK in addition to other oncogenic pathways like ROS1, c-MET, EGFR, etc. These strategies seek to improve therapy efficacy, address resistance mechanisms, and provide treatment alternatives for patients with intricate molecular profiles. The aim of this review is to summarize the introduction to ALK and the synergy between ALK and other anti-tumor targets, recent developments in the synthesis of various dual inhibitors of the ALK. We also thoroughly discussed their design concepts, structure-activity relationships (SARs), preclinical and clinical data as well as in silico studies to provide ideas for further development of novel ALK based dual inhibitors.

News (Medical) associated with Lorlatinib

27 Feb 2025

·www.prnewswire.com

Nuvalent Outlines Pipeline and Business Progress, Reiterates Key Anticipated Milestones, and Reports Fourth Quarter and Full Year 2024 Financial Results

Topline pivotal data expected in 2025 for both TKI pre-treated ROS1-positive and TKI pre-treated ALK-positive NSCLC populations First NDA submission planned for mid-year 2025 towards potential first approval in 2026 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC population Development strategies in place for TKI-naïve populations, including planned initiation of ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC in first half of 2025 Implemented global Expanded Access Programs for zidesamtinib and neladalkib, in line with goal of prioritizing patient access CAMBRIDGE, Mass., Feb. 27, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business progress, reiterated key anticipated milestones, and reported fourth quarter and full year 2024 financial results. "The efficient execution by the Nuvalent team to date reflects a shared sense of urgency driven by patient need for additional treatment options – a need that we believe has been clearly demonstrated by the robust enrollment momentum in our ARROS-1 and ALKOVE-1 trials," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "We believe we are on track to report pivotal data for TKI pre-treated patients from both trials this year and to submit our first NDA by mid-year 2025." Ms. Noci continued, "In parallel to advancing initial registration paths for zidesamtinib and neladalkib for TKI pre-treated patients, we continue to work with regulators towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC. Development programs for TKI-naïve patients are underway for both our ROS1 and ALK programs. To ensure patient access to these therapies, we are also pleased to announce the recent launch of global Expanded Access Programs for patients who are eligible and have no other treatment options outside of a clinical trial." "As we transition towards becoming a fully integrated commercial-stage biopharmaceutical company, we reiterate our commitment to meeting the medical needs of patients by advancing our programs as quickly as possible," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "This is an important time for Nuvalent and with a steady cadence of anticipated milestones across our pipeline this year, a strong balance sheet and a dedicated and proven team at the helm, we believe we are well-positioned to deliver on our near-, mid- and long-term goals." Recent Pipeline Progress and Anticipated Milestones ROS1 Program Nuvalent has implemented a global Expanded Access Program (EAP) for zidesamtinib for eligible patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received at least one prior ROS1 tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial. As of December 31, 2024, a total of 430 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib for patients with advanced ROS1-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated and TKI-naïve patients with advanced ROS1-positive NSCLC. The company expects to report pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC in the first half of 2025 in support of an anticipated New Drug Application (NDA) submission by mid-year 2025, with an initial target indication of TKI pre-treated patients with advanced ROS1-positive NSCLC. The company plans to continue engagement with the U.S. Food and Drug Administration (FDA) on accelerated opportunities towards a potential line-agnostic indication supported by the ongoing TKI-naïve cohort in the Phase 2 portion of the ARROS-1 trial. ALK Program Nuvalent has implemented a global EAP for neladalkib for eligible patients with locally advanced or metastatic ALK-positive NSCLC who have previously received lorlatinib or a second-generation ALK TKI and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial. As of December 31, 2024, a total of 596 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ALKOVE-1 Phase 1/2 trial of neladalkib for patients with advanced ALK-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated patients. The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025. Nuvalent plans to initiate the ALKAZAR Phase 3 trial, its front-line development strategy for the company's ALK program, in the first half of 2025. The Phase 3 ALKAZAR trial will be a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA® (alectinib) monotherapy, reflecting input from collaborating physician-scientists and alignment with the FDA. HER2 Program Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025. Business Updates Appointed Grant Bogle to Board of Directors: As previously announced, Nuvalent appointed Grant Bogle to its board of directors in December 2024. Mr. Bogle brings nearly four decades of proven leadership in building and growing biotechnology companies to the Nuvalent board. Throughout his career, he has served in senior leadership roles at several specialty pharmaceutical and biotechnology companies and worked alongside oncologists as part of the leadership of U.S. Oncology, the largest network of community oncology practices in the United States. He has a proven track record of success in the field of oncology and has guided numerous products from early-stage development to commercialization. Most recently, Mr. Bogle was the Chief Executive Officer at Epizyme, Inc., and oversaw the 2022 acquisition of the company by Ipsen. Prior to that, Mr. Bogle was Senior Vice President and Chief Commercial Officer of TESARO, which was acquired by GlaxoSmithKline in 2018. Earlier, he served as Senior Vice President of Pharmaceutical and Biotech Solutions at McKesson Specialty Health (formerly U.S. Oncology). Fourth Quarter and Full Year 2024 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of December 31, 2024. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028. R&D Expenses: Research and development (R&D) expenses were $69.4 million for the fourth quarter of 2024 and $217.8 million for the year ended December 31, 2024. G&A Expenses: General and administrative (G&A) expenses were $16.9 million for the fourth quarter of 2024 and $62.6 million for the year ended December 31, 2024. Net Loss: Net loss was $74.8 million for the fourth quarter of 2024 and $260.8 million for the year ended December 31, 2024. About Nuvalent Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; Nuvalent's estimated cash runway; the expected timing of data announcements, clinical trial initiations, FDA submissions and potential product approval; the clinical development programs for zidesamtinib, neladalkib and NVL-330; the timing of the ALKAZAR trial; the potential clinical effects of Nuvalent's product development candidates; the design and enrollment of Nuvalent's clinical trials, including for ARROS-1 and ALKOVE-1 their intended pivotal registration-directed design; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib and NVL-330; the implications of data readouts and presentations; timing and content of potential discussions with FDA regarding potential accelerated approval pathways; Nuvalent's potential buildout of a commercial infrastructure; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies and clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our zidesamtinib or neladalkib product candidates; risks that Nuvalent may not achieve the goals and milestones set forth in its OnTarget 2026 operating plan; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations, including the ARROS-1, ALKOVE-1, ALKAZAR and HEROEX-1 trials; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Financial StatementPhase 3Phase 2Executive Change

04 Feb 2025

·pharma.economictimes.indiatimes.com

Can Custom Duty exemptions alleviate the high-price burden for cancer patients?

New Delhi: With more than 1.5 million active cases across the country, the prevalence of cancer in India has certainly outpaced the available treatment interventions. However, what makes the situation even worse is the sky-high cost of treatment, which makes these therapies inaccessible to many patients, leaving them in a desperate struggle to secure financial aid and loans for life-saving medicines. A walk around Mumbai’s Tata Memorial Hospital, India’s premium cancer care institution, shows the appalling situation. T he entrance is always overflowing with patients from across the country, while many managing to live in makeshift shelters in extreme financial distress to cope with costs of treatment. A study showed a small fraction of Indians, roughly 3 per cent can afford expensive immunotherapies in India, making it a big challenge for public health establishments to reach modern medicines to the low income strata. To confront this growing crisis, the government has opted for a strategy of waiving customs duties on life-saving medications, thereby reducing import costs and hoping to translate these savings into more affordable treatment options for patients. The Finance Minister said in her Budget 2025 speech, “To provide relief to patients, particularly those suffering from cancer, rare diseases, and other severe chronic conditions, I propose to add 36 life-saving drugs and medicines to the list of medicines fully exempted from Basic Customs Duty .” She also proposed to add “six life-saving medicines to the list attracting a concessional customs duty of 5 percent.” The government order states, “In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act, 1962 (52 of 1962), the Central Government, on being satisfied that it is necessary in the public interest to do so,” has exempted Basic Customs Duty on 36 life-saving medications. A rough analysis of the list shows that out of the 36 medications, 25 are indicated for the treatment of various types of cancer. Feb 4, World Cancer Day , is the perfect time to assess whether exempting customs duties could make a significant difference to patient expenses. The majority of these drugs are protected by patents, granting them global exclusivity, and are marketed by major pharmaceutical giants such as Merck, Roche, GSK, and AstraZeneca. Strikingly, in the previous Budget 2024, the government announced the exemption of customs duty on three cancer drugs—Osimertinib, Durvalumab, and Trastuzumab Deruxtecan. The first two medications are indicated for lung cancer, while the latter is used in the treatment of breast cancer. All three are marketed by UK pharma giant AstraZeneca. According to the government, “Drugs/medicines generally attract a basic customs duty of 10 percent, while some categories of life-saving drugs/vaccines attract a concessional rate of 5 percent or nil.” The Basic Customs Duty (BCD) is calculated over the customs value, which is the accumulation of the CIF cost where C represents the cost of goods, I stands for insurance, and F accounts for freight or logistics costs. Besides BCD, the government levies a social welfare surcharge of 10 per cent, calculated over the BCD value, and a 5 per cent Integrated Goods and Services Tax (IGST), calculated over the accumulated figure of CIF value and BCD of the imported goods. Speaking to ET Pharma, Leena Menghaney, a lawyer and public health activist, stressed, “The customs duty waiver on some of the exorbitantly priced cancer and rare disease drugs is a welcome move, but it is like a band-aid and does not address the underlying problem of high prices due to patent monopolies that block local production.” “India is a country where half the population lives on less than $1 per day and bears a large public health burden for cancers. How can patients pay for patented medicines like Keytruda ?” she added. While industry stakeholders are still analysing the net impact of the announcement, Dr.B. S. Ajaikumar, Executive Chairman of Healthcare Global Enterprises Limited, said, “The exemption of customs duty will have an impact of 5-10 percent on the price of drugs, and this development will primarily benefit cash-paying patients, with some benefit extending to those utilizing insurance.” Bhanu Prakash Kalmath, a consultant at Grant Thornton Bharat LLP, underlined, “The final reduction will depend on manufacturers, hospitals, and supply chains. This move directly reduces import costs and supports broader access to essential treatments. It also benefits insurance providers, government health schemes like Ayushman Bharat , and Patient Assistance Programs (PAPs).” Under the Patient Assistance Programs (PAP) offered by pharmaceutical companies, medicines are provided in 1+1 or 2+1 packages, where the patient pays for one or two drugs and receives an additional one free of cost. However, under the condition of anonymity, an expert shared that very few patients in the country are currently covered under PAP programs. Additionally, at times, the last-stage providers (mostly hospitals) that stock these drugs apply a profit margin over the products. Furthermore, it is crucial to note that while the Finance Minister’s announcement has exempted customs duties, patients still have to contend with the Maximum Retail Price (MRP) of drugs. The MRP is compiled based on several other costs, as post-import, the product often requires special storage, handling, and packaging before distribution to retail outlets. The distribution costs include transportation to wholesalers and retail outlets, along with the distributor’s margin. To make novel treatments truly affordable for the Indian demographic, Menghaney emphasised, “The country needs to boost local production and competition by granting a compulsory license clause. This would cut the cost of the drug by allowing another company to manufacture the therapy, even though it is still under patent.” “In the past, such measures have slashed prices by introducing local generic versions of cancer drugs—by an astounding 97 percent,” she added. The high price of cancer drugs has long been a contentious issue across low- and middle-income countries (LMICs), including India. However, given the scale and severity of the problem, it categorically requires a more holistic solution—one that ensures benefits are truly materialized for patients. As philanthropist Bill Gates once said, “The good news is that we have the tools to prevent most diseases. But the bad news is that not enough people are getting them.” List of Cancer Drugs to exempted from BCD under Budget 2025-26 S. No. Drug Company Brand Name MRP (INR) 1. Pembrolizumab MSD (Merck, Sharp & Dohme) Keytruda 2,16,500 2. Lorlatinib Pfizer Lorbrena 10,400 3. Dacomitinib Pfizer Vizimpro 2,135 4. Inotuzumab Ozogamicin Pfizer Besponsa 3,30,000 5. Ribociclib Novartis Kisqali 1,125 6. Dabrafenib Novartis Tafinlar 1,516 7. Selumetinib AstraZeneca Koselugo - 8. Fulvestrant AstraZeneca Faslodex 21,100 9. Acalabrutinib AstraZeneca Calquence 15,147 10. Olaparib AstraZeneca Lynparza 5,416 11. Amivantamab J&J Rybrevant 98,500 12. Teclistamab J&J Tecvayli 76,218 13. Daratumumab and hyaluronidase-fih J&J Darzalex Faspro 2,64,600 14. Ibrutinib J&J Imbruvica 3,644 15. Bortezomib J&J Velcade 18,060 16. Daratumumab J&J Darzalex 18,900 17. Cetuximab Merck Specialties (Merck KGaA) Erbitux 21,250 18. Avelumab Merck Specialties Bavencio - 19. Tepotinib Merck Specialties Tepmetko 5,094 20. Brentuximab Vedotin Takeda Adcetris 2,22,709 21. Vedolizumab Takeda Entyvio - 22. Atezolizumab Roche Tecentriq 2,77,708 23. Pertuzumab+trastuzumab Roche Phesgo 2,80,000 24. Polatuzumab vedotin Roche Polivy 2,22,225 25. Alectinib Roche Alecensa 2,215 Note* the above price is without any deduction and of lowest dosage strength as some of the drugs are available in multiple strengths and their prices also very depending upon that particular strength. By Abhijeet Singh ,

ImmunotherapyBiosimilar

01 Feb 2025

·pharma.economictimes.indiatimes.com

Govt Attempts to Overcome High-Price Challenge by Exempting Basic Customs Duty in Budget 2025

New Delhi : Continuing its focus on addressing the challenge of skyrocketing drug prices , the Finance Minister, in her eighth Budget speech for the fiscal year 2025-26, announced a full exemption of basic customs duty (BCD) for 36 life-saving medications indicated for critical conditions such as cancer, autoimmune diseases, and rare disorders. “To provide relief to patients, particularly those suffering from cancer, rare diseases, and other severe chronic conditions, I propose to add 36 lifesaving drugs and medicines to the list of medicines fully exempted from Basic Customs Duty,” the Finance Minister said in her Budget speech. Previously, the exemption of BCD on these drugs was conditional on their availability free of cost under drug companies' Patient Assistance Programmes (PAP). Among these 36 medications, 25 are indicated for the treatment of different types of cancer, five are prescribed for rare disorders, two for respiratory diseases, three for autoimmune conditions, and one is used in the treatment of retinal diseases. The majority of these drugs are protected by patents, granting them global exclusivity, and are marketed by major pharmaceutical giants such as Merck, Roche, GSK, and AstraZeneca. Notably, in the previous Budget, the government announced the exemption of customs duty on three cancer drugs—Osimertinib, Durvalumab, and Trastuzumab Deruxtecan. The first two medications are indicated for lung cancer, while the latter is used in the treatment of breast cancer patients. Sharing his views on this announcement, Arjun Juneja, COO of Mankind Pharma, said, “The exemption of Basic Customs Duty on 36 life-saving drugs makes critical treatments, especially for oncology and rare diseases, more affordable. It aligns with the government’s vision of a self-reliant India, lays a solid foundation for the pharmaceutical sector , and enhances healthcare accessibility .” “The addition of 36 life-saving drugs to the list of medicines fully exempted from basic customs duty, along with six more medicines under concessional duty, will significantly reduce treatment costs for patients,” added DS Negi, CEO of Rajiv Gandhi Cancer Institute & Research Centre (RGCIRC). Commenting on its impact on patients, Dr. Tarang Gianchandani, CEO of Sir H.N. Reliance Foundation, said, “The basic customs duty exemption on 36 life-saving drugs, including those for cancer and rare diseases, ensures that critical treatments remain within reach for countless patients and their families, bringing hope.” List of 36 Medications given BCD Exemptions: S.No. Drug Company Clinical Indication 1. Pembrolizumab MSD (Merck, Sharp & Dohme) Cancer 2. Lorlatinib Pfizer Cancer 3. Dacomitinib Pfizer Cancer 4. Inotuzumab Ozogamicin Pfizer Cancer 5. Ribociclib Novartis Cancer 6. Dabrafenib Novartis Cancer 7. Selumetinib AstraZeneca Cancer 8. Fulvestrant AstraZeneca Cancer 9. Acalabrutinib AstraZeneca Cancer 10. Olaparib AstraZeneca Cancer 11. Amivantamab J&J Cancer 12. Teclistamab J&J Cancer 13. Daratumumab and hyaluronidase-fih J&J Cancer 14. Ibrutinib J&J Cancer 15. Bortezomib J&J Cancer 16. Daratumumab J&J Cancer 17. Cetuximab Merck Specialties (Merck KGaA) Cancer 18. Avelumab Merck Specialties Cancer 19. Tepotinib Merck Specialties Cancer 20. Brentuximab Takeda Cancer 21. Vedolizumab Takeda Cancer 22. Atezolizumab Roche Cancer 23. Pertuzumab+trastuzumab Roche Cancer 24. Polatuzumab vedotin Roche Cancer 25. Alectinib Roche Cancer 26. Benralizumab Astrazeneca Respiratory Disease (Asthma) 27. Mepolizumab GSK Respiratory Disease (Severe Asthma) 28. Ustekinumab J&J Autoimmune Disease (Psorasis) 29. Ocrelizumab Roche Autoimmune Disease (Multiple sclerosis) 30. Luspatercepto Bristol Myers Squibb Autoimmune Disease (Anemia) 31. Velaglucerase Takeda Rare Disorder (Type 1 Gaucher disease) 32. Agalsidase Alpha Takeda Rare Disorder (Fabry disease) 33. Idursulphase Takeda Rare Disorder (Hunter syndrome) 34. Risdiplam Powder Roche Rare Disorder (SMA) 35. Emicizumab Roche Rare Disorder (Hemophillia) 36. Faricimab Roche Retinal Disease By Online Bureau ,

100 Deals associated with Lorlatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11012	Lorlatinib	L01XE44	DB12130

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	United States	Pfizer Inc.	02 Nov 2018
Non-Small Cell Lung Cancer	Japan	Pfizer Inc.	21 Sep 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	China	Pfizer Inc.	27 May 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 2	China	CStone Pharmaceuticals Co. Ltd.	27 May 2022
ALK-positive anaplastic large cell lymphoma	Phase 2	Italy	Pfizer Inc.	10 Oct 2017
Anaplastic Large-Cell Lymphoma	Phase 2	Italy	Pfizer Inc.	10 Oct 2017
metastatic non-small cell lung cancer	Phase 2	United States	Pfizer Inc.	18 Dec 2015
metastatic non-small cell lung cancer	Phase 2	Japan	Pfizer Inc.	18 Dec 2015
metastatic non-small cell lung cancer	Phase 2	Australia	Pfizer Inc.	18 Dec 2015
metastatic non-small cell lung cancer	Phase 2	Spain	Pfizer Inc.	18 Dec 2015
Advanced Lung Non-Small Cell Carcinoma	Phase 2	United States	Pfizer Inc.	08 Jan 2014
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Japan	Pfizer Inc.	08 Jan 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	51	Lorlatinib	gwsiicroct(fitpsprufi) = Hypertriglyceridemia (36.4%), hypercholesterolemia (27.3%), pedal edema (18.2%), weight gain (15.2%), mood effects (2%) fkbeaomigx (uqokylfyfw ) View more	Positive	30 May 2025
ASCO2025	Phase 2	-	8	Lorlatinib 100 mg/day	jwzzzyfyes(pjwocaazdq) = dxwniencyt arfvthfvqo (priyrlkzas, 72 - 100) View more	Positive	30 May 2025
ASCO2025	Not Applicable	Mesenchymal lymphoma kinase (ALK) gene mutation	-	Lorlatinib	epaptjncva(mkdloepdzx) = Death ROR (95% CI) 5.81 (5.39-6.27), PRR (Chi-Square) 5.44 (2634.70), IC (IC-2SD) 2.44 (2.32), EBGM (EBGM05) 5.43 (5.03) hceqlcmnro (ucrdukebuu ) View more	Positive	30 May 2025
TOG study (ASCO2025)	Not Applicable	Advanced Lung Non-Small Cell Carcinoma Second line ROS1-positive	52	Lorlatinib	ijpcsxwszi(saqylpczln) = xyggqiokci bwcokwqupf (guentnumps ) View more	Positive	30 May 2025
NCT03052608 (CROWN, ASCO2025)	Phase 3	-	-	Lorlatinib 100 mg once daily	aktrmbvdjp(ruzxhbyttx) = Of the 30 AEs leading to 1 dose reduction, 27% of events resolved and 13% partially resolved. Of the 59 AEs leading to 2 dose reductions, 46% of events resolved and 5% partially resolved. ckexrkkqoz (tlcxopmypn )	Positive	30 May 2025
ChiCTR2400092915 (ASCO2025)	Phase 4	Hyperlipidemias ALK fusion mutations	120	Lorlatinib	splldsdudi(zuwgrjcqep) = Five cases developed cardiovascular events, but none of them led to death wlzxsfaskm (ehpmxqbjhh ) View more	Positive	30 May 2025
ChiCTR2400092915 (ASCO2025)	Phase 4	Hyperlipidemias ALK fusion mutations	120	Statins		Positive	30 May 2025
AACR2025	Not Applicable	First line	63	First-line lorlatinib treatment	jgjpxdfrwp(mqbtxijuwa) = rnmlrfgmup hacqttwexq (kdnisuifcy ) View more	Positive	29 Apr 2025
AACR2025	Not Applicable	First line	63	Later-line lorlatinib treatment	jgjpxdfrwp(mqbtxijuwa) = abmgqmuvud hacqttwexq (kdnisuifcy ) View more	Positive	29 Apr 2025
AACR2025	Not Applicable	Second line ctDNA analysis \| TP53 mutations \| ALK fusions ... View more	27	Lorlatinib	fylmgccdcf(bfqqenggzl) = jhavmoiagg zrbywzpsux (esckknqayn ) View more	Positive	29 Apr 2025
NCT04362072 (ESMO_ELCC2025) Manual	Phase 4	ALK positive Non-Small Cell Lung Cancer Second line ALK Positive	71	Lorlatinib 100 mg once daily	orkhbjqjop(cuigablbkf) = lpkmjrwbaj pmmctayqsv (vuxitvdewb, 31 - 55) View more	Positive	26 Mar 2025
NCT04362072 (ESMO_ELCC2025) Manual	Phase 4		71	Lorlatinib 100 mg once daily (pts with CNS metastases)	xeuahzoagb(zrffmczipr) = rqtktzxeea tsiekhbxdi (ccdapgcpkw, 28 - 66)	Positive	26 Mar 2025
CROWN and ALEX (ESMO_ELCC2025)	Not Applicable	Brain metastases First line	-	Lorlatinib	sdqtxnlmth(dviegcbepm): HR = 0.51 (95% CI, 0.27 - 0.94) View more	Positive	26 Mar 2025
CROWN and ALEX (ESMO_ELCC2025)	Not Applicable	Brain metastases First line	-	Alectinib		Positive	26 Mar 2025

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