CELLTRION-HEALTHCARE
19.8.2022 04:49:05 CEST | Business Wire | Press release
Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma™ (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin® , for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.
“The European Commission’s approval of Vegzelma™ will increase access to treatment for patients living with certain types of cancer at an affordable price,” said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. “With proven similarities in efficacy and safety compared to the reference product Avastin® , Vegzelma™ will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year.”
The EC approval of Vegzelma™ follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.
Today’s approval is based on the totality of evidence, including the phase III pivotal trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Results showed that, as a first-line treatment, Vegzelma™ is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.2
Vegzelma™ (CT-P16) is Celltrion’s third oncology biosimilar approved for use in the EU, following the approval of Truxima® (biosimilar rituximab) and Herzuma® (biosimilar trastuzumab). Vegzelma™ was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA) in September 2021. Approval is expected during the third quarter of 2022.
- ENDS -
Notes to Editors:
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com
About Vegzelma™ (CT-P16, biosimilar bevacizumab)
Vegzelma™ is an anti-cancer monoclonal antibody treatment biosimilar to Avastin® (bevacizumab). Vegzelma™ is a recombinant humanised monoclonal antibody which binds to VEGF, the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.3 In the EU, Vegzelma™ is indicated for the treatment of patients with metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, ovarian cancer, advanced cervical cancer and metastatic breast cancer.
References
1 Avastin is a registered trademark of Genentech Inc.
2 Ohe Y et al., Randomized Phase III Study Comparing the Efficacy and Safety of CT-P16, a New Biosimilar, to Reference Bevacizumab (Avastin) In Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC). Proceedings: American Association for Cancer Research (AACR) Annual Meeting 2022; April 8-13, 2022 New Orleans, Louisiana.
3 European Medicines Agency Summary of Product Characteristics (SmPC), Avastin. Available at https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf [Last accessed August 2022].
View source version on businesswire.com: https://www.businesswire.com/news/home/20220817005324/en/
Link:
Social Media:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Andersen Consulting tilføjer samarbejdsfirmaet TechSparq25.10.2026 06:09:00 CET | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for teknologi og forretningstransformation gennem en samarbejdsaftale med TechSparq, en amerikansk virksomhed, der kombinerer strategi, commerce engineering og ai med praktisk implementering. TechSparq er et digitalt konsulenthus, der tilbyder strategi- og rådgivningstjenester, commerce engineering samt tjenester inden for ai og agentbaseret handel til virksomheder inden for detailhandel og forbrugsgoder, luksus og mode samt e-handel og direkte salg til forbrugere. Virksomheden har hovedkontor i Oregon og kombinerer strategisk planlægning med praktisk implementering for at hjælpe kunderne med at udvikle deres digitale initiativer, kundeoplevelse og driftsmodeller. "Vi etablerede vores virksomhed for at bygge bro mellem dem, der udvikler strategien, og dem, der har ansvaret for at føre den ud i livet," udtalte Dedrick Boyd, stifter af og administrerende direktør for TechSparq. "Vores samarbejde med Andersen Consulting giver os mulighed
BeOne Presents Compelling Data in Hard-to-Treat Liver and Lung Cancers at ESMO 202624.10.2026 10:15:00 CEST | Press release
Potential first-in-class GPC3 x 4-1BB bispecific achieves a 36% confirmed response rate at Phase 3 dose and favorable safety profile in heavily pretreated liver cancerBrain-penetrant PRMT5 inhibitor shows promising antitumor and CNS activity in the largest publicly shared MTAP-deficient datasetFirst clinical data of CEA-targeting ADC demonstrates encouraging and sustained responses in CEAhigh NSCLC BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from multiple differentiated investigational medicines across its priority solid tumor disease areas at the European Society for Medical Oncology (ESMO) Congress 2026 (October 23–27, Madrid). The presentations span gastrointestinal, lung, and breast cancers, and reflect the growing momentum of BeOne’s solid tumor franchise. Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said: “At ESMO, we are showing how our strategy of matching the right modality to dise
Phase 3 RAINIER Results Supporting Best-in-Class Potential of Povetacicept in IgA Nephropathy Published in the New England Journal of Medicine and Presented at the American Society of Nephrology Kidney Week 202623.10.2026 19:42:00 CEST | Press release
- Vertex is on track for the U.S. FDA Prescription Drug User Fee Act (PDUFA) date of November 30 for potential accelerated approval of povetacicept –- Data published in NEJM and presented at ASN highlight povetacicept’s unique trifecta of efficacy, favorable safety, and the simplicity of dosing at-home every 4 weeks with a low-volume autoinjector –- Data presented at ASN include a qualitative study examining patient perspectives on current and emerging IgAN therapies, showing that 96% of participants preferred an autoinjector over a prefilled syringe, and 80% of participants preferred dosing every 4 weeks versus weekly dosing - - New clinical studies of povetacicept underway including a study evaluating patient experience on povetacicept administered via autoinjector - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the publication of Phase 3 RAINIER results for povetacicept in the New England Journal of Medicine (NEJM), presentation of these data at the American Soc
BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer23.10.2026 16:15:00 CEST | Press release
New data from HERIZON-GEA-01 Phase 3 trial show 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy, and median OS reaching 27 monthsTEVIMBRA-containing arm was associated with a four-month longer median OS compared with ZIIHERA plus chemotherapy BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new survival results from the planned second interim analysis (IA2) and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA® (tislelizumab) plus ZIIHERA® (zanidatamab) and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (LBA79). Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne,
Lifezone Metals Confirms Advanced Negotiations with Orion CMC on Kabanga Nickel Project23.10.2026 16:10:00 CEST | Press release
Lifezone Metals Limited (NYSE: LZM) notes comments made today by Oskar Lewnowski, Founder and Group Chief Executive of Orion Resource Partners, in an interview with Bloomberg Television regarding the Company’s Kabanga Nickel Project in Tanzania. In response to inbound inquiries from media outlets and investors following the interview, the Company can confirm that negotiations with Orion Critical Mineral Consortium (Orion CMC) regarding a significant equity investment into the Kabanga Nickel Project are at an advanced stage. The Orion CMC is a global investment platform launched by Orion Resource Partners in partnership with the U.S. International Development Finance Corporation (DFC) and Abu Dhabi's sovereign investor ADQ. As previously announced, the Company has been running a competitive process, led by Standard Chartered Bank, to secure a strategic investment into the Kabanga Nickel Project. Social Media LinkedIn | X | YouTube About Lifezone Metals Lifezone Metals (NYSE: LZM) is com
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom