Bevacizumab

Provides a new treatment option as the world’s first therapeutic drug for neurofibromatosis type 2, a disease with limited treatment options Approval based on the results from an investigator-initiated Japanese Phase II clinical study June 19, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of neurofibromatosis type 2 (NF2) for the anti-cancer agent/humanized anti-VEGF*1 monoclonal antibody Avastin® Intravenous Infusion 100 mg/4 mL and 400 mg/16 mL [generic name: bevacizumab (genetical recombination)] (hereinafter, “Avastin”). Avastin is the first drug approved in the world for the treatment of this disease. “We are very pleased to deliver Avastin as the world’s first therapeutic drug for neurofibromatosis type 2 in Japan. NF2 is a rare disease that causes symptoms such as hearing loss and dizziness, significantly impacting patients’ daily lives, and there has been a strong need for effective treatment options. Avastin represents a new therapeutic option, suggesting potential for the maintenance or improvement of hearing and a trend toward tumor reduction. We will continue our efforts to promptly provide appropriate use information so that we can contribute to patient treatment and improvement in quality of life,” said Chugai’s President and CEO, Dr. Osamu Okuda. This approval is based on the results from the investigator-initiated Japanese Phase II clinical study, the BeatNF2 study, which evaluated the efficacy and safety of Avastin in NF2. Approval Information *Relevant sections only, with modifications underlined Indications: ◯ Unresectable advanced or recurrent colorectal cancer ◯ Unresectable advanced or recurrent non-small cell lung cancer excluding squamous cell carcinoma ◯ Inoperable or recurrent breast cancer ◯ Malignant glioma ◯ Ovarian cancer ◯ Advanced or recurrent cervical cancer ◯ Unresectable hepatocellular carcinoma ◯ Neurofibromatosis type 2 Dosage and Administration: The usual adult dosage is 5 mg/kg (body weight) of bevacizumab (genetical recombination) administered by intravenous infusion every two weeks [Reference Information] Chugai Files for Additional Indication of Avastin for the Treatment of Neurofibromatosis Type 2 (News release dated September 24, 2025) https://www.chugai-pharm.co.jp/english/news/detail/20250924153000_1185.html The BeatNF2 study (FMU2019-01-NF2 study / jRCT2080224914) is an investigator-initiated, multicenter, domestic Phase II, placebo-controlled, double-blind, randomized clinical study conducted in Japan to evaluate the efficacy and safety of Avastin in patients with NF2, a rare hereditary disease. Twelve institutions in Japan, including Fukushima Medical University Hospital, participated in the study. The study enrolled 62 patients. During the initial treatment period, Avastin or placebo was administered every two weeks through week 22. From week 24 to week 46, all patients received Avastin every two weeks. During the follow-up period, Avastin could be administered up to six times if the attending physician judged disease progression. The primary endpoint, “the proportion of patients with improved hearing at 24 weeks after treatment initiation compared to baseline, based on the evaluation using maximum speech discrimination score*2,” was 16.1% (5/31; 95% CI: 5.5-33.7) in the Avastin group and 3.2% (1/31; 95% CI: 0.1-16.7) in the placebo group, with no statistically significant difference (P = 0.0858). Meanwhile, improvement in hearing measures and a trend toward reduction in tumor volume, a secondary endpoint, were suggested during the treatment period. Regarding safety, adverse reactions were observed in 57.4% (35/61) of patients who received Avastin, and hypertension was the most common adverse reaction at 18.0% (11/61). *1 VEGF：Vascular Endothelial Growth Factor *2 Maximum speech discrimination score is an indicator of speech comprehension ability. It refers to the percentage of correct answers in a monosyllabic word recognition test at the volume level that yields the highest accuracy while adjusting sound intensity. The higher this value, the better one’s ability to accurately understand speech when sounds are audible. It also serves as a measure for evaluating the effectiveness of hearing aids. NF2 is an autosomal dominant hereditary disease characterized by bilateral acoustic nerve tumors (vestibular schwannomas). Symptoms associated with these tumors include hearing loss, dizziness, unsteadiness, and tinnitus. Additionally, symptoms related to spinal schwannomas may include numbness, sensory impairment, and weakness in the limbs. Management of vestibular schwannomas includes observation, surgery, and radiation therapy. While these tumors are benign and may show minimal growth, surgical removal may be performed when symptoms develop or tumor growth is evident, which may affect long-term prognosis. Preservation of hearing through surgery is difficult, and there remains a risk of postoperative neurological complications. According to overseas reports, NF2 is a rare disease with an incidence of approximately 1 in 25,000 to 60,000 individuals. In Japan, approximately 800 patients submitted clinical registry data between 2009 and 2013. Onset is most common in individuals in their teens to twenties. Avastin is an antibody medicine that binds specifically to VEGF2, which plays an important role in angiogenesis essential for tumor growth and metastasis, thereby inhibiting its activity. In Japan, Avastin was launched in June 2007 and is positioned as one of the standard therapies in treatment guidelines for various cancers. It has been approved for seven indications: unresectable advanced or recurrent colorectal cancer, unresectable advanced or recurrent non-squamous non-small cell lung cancer, inoperable or recurrent breast cancer, malignant glioma, ovarian cancer, advanced or recurrent cervical cancer, and unresectable hepatocellular carcinoma. Trademarks used or mentioned in this release are protected by law. The content above comes from the network. if any infringement, please contact us to modify.

VVD-214 targets Werner helicase (WRN), a synthetic lethal vulnerability in cancers with high microsatellite instability (MSI-high) or deficient mismatch repair (dMMR) Global Phase Ib clinical study will evaluate VVD-214 in patients with previously treated MSI-high or dMMR colorectal cancer Progress of VVD-214 demonstrates continued advancement of Vividion’s clinical development capabilities and the potential of its covalent-first chemoproteomics approach to unlock challenging drug targets SAN DIEGO & BERLIN--(BUSINESS WIRE)-- Vividion Therapeutics , Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, today announced that the first patient has been dosed in a Phase Ib combination clinical trial evaluating VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The study is evaluating VVD-214 in combination with bevacizumab in patients with microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer whose disease has progressed following prior lines of therapy. “Colorectal cancer remains one of the most common and challenging cancers to treat worldwide, and a substantial proportion of cases are driven by underlying defects in DNA repair,” said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. “VVD-214 reflects Vividion’s continued focus on uncovering and advancing therapies against critical cancer dependencies that have historically been difficult to target, including WRN, with the potential to deliver new precision medicines that address this urgent need.” VVD-214 is an investigational oral small-molecule inhibitor of WRN, a DNA repair enzyme that has emerged as a highly sought-after synthetic lethal target for cancers with microsatellite instability. Tumors that are MSI-high or dMMR rely on WRN to maintain DNA replication and repair despite their underlying genomic instability. By inhibiting WRN, VVD-214 is intended to cause lethal DNA damage in cancer cells while minimizing harm to normal cells, offering a potential precision medicine approach for patients with cancers such as colorectal, endometrial, ovarian and gastric tumors. “Advancing precision oncology therapies for cancers driven by specific molecular vulnerabilities is a key focus of Bayer’s oncology strategy,” said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division. “Targeting WRN represents a promising new therapeutic approach for genetically distinct subsets of some of the most common cancers worldwide, and we are encouraged to see VVD-214 continue to advance through clinical development.” The global Phase Ib clinical trial ( NCT06004245 ) is planned to enroll patients at clinical sites across the U.S., Australia, Belgium, Canada, China, Denmark, France, Malaysia, South Korea, Spain, and the U.K. Preliminary data from the Phase Ia study presented at the American Association for Cancer Research (AACR) 2025 Annual Meeting showed that VVD-214 was well tolerated with early signals of activity. About Vividion Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical-stage biopharmaceutical company utilizing novel discovery technologies to unlock difficult-to-drug targets with strong disease-links, and to develop small molecule precision therapeutics for devastating cancers and immune disorders. The company’s platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high-value, traditionally undruggable targets in oncology and immunology. For more information, please visit . About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on Facebook: aka (2026-0058) Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Contacts Vividion Media Contact : Laurie Sherman, phone +1 858 630 8246 Email: media@vividion.com Bayer Global Media Contact : Anna Kanmaz, phone +49 174 14 63 541 Email: anna.kanmaz@bayer.com Bayer U.S. Media Contact: Elaine Colon, phone +1 732 236 1587 Email: elaine.colon@bayer.com