European Commission Approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer
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™ isindicated 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.
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].
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
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
New Study From Egon Zehnder and Kearney Debunks the Myth of a Workplace Generational Divide28.9.2022 16:00:00 CEST | Press release
Egon Zehnder, the world’s preeminent leadership advisory firm, in partnership with Kearney, a leading global management consulting firm, today released findings from a new survey with over 8,000 respondents from eight different countries dismissing the myth of a generation divide in the workplace and showing that despite what is often believed, Gen Z, Millennials, Gen X and Boomers are more alike than different when it comes to workplace matters. The survey, titled “Different Generations, Same Ideals: What Workers of All Ages Value in their Jobs,” analyzed the similarities and differences among generations and found that they share more commonalities, especially when it comes to personal well-being, work-life balance, and desired traits from leadership. The most notable difference between the generations is how each group defines and plans to achieve their career desires. Key Findings from the survey include: Personal well-being, stability, and work-life balance matter more than money
BYD Announces Pre-sale Prices of European Passenger Car Range28.9.2022 15:35:00 CEST | Press release
BYD announces the pre-sale prices of its new European passenger car range. The world’s leading manufacturer of new energy vehicles and power batteries immediately introduces three full-electric passenger vehicles which will be delivered to Norway, Sweden, Denmark, the Netherlands, Belgium, Luxembourg and Germany. Before the end of the year customers in France and the United Kingdom will also have access to BYD’s zero-emission vehicles. After that, more dealers will be appointed supporting BYD’s plans to cover all major markets in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220928005587/en/ BYD Europe Product Premiere 2022 The pre-sale price for the BYD ATTO 3 is € 38,000. The BYD HAN and TANG pre-sale prices are € 72,000. These pre-sale prices apply to Germany as a reference for Europe and may differ from country to country. The three full-electric BYD vehicles are technologically advanced and well-suited to the e
Monrol Will Establish a Legal Entity and Manufacturing Facility in Germany28.9.2022 15:27:00 CEST | Press release
Following an ongoing assessment of its entire operation, Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) has decided to establish a legal entity and manufacturing facility in Germany. The new facility will focus on the manufacture of SPECT products and radiopharmaceutical products for radioligand therapy(*) such as Gallium-68 generator and n.c.a Lutetium-177. Developed by Monrol R&D teams, these products are widely used in the production of radiopharmaceuticals for cancer patients. The facility will also have a dedicated division for state-of-the art cGMP Contract Development and Manufacturing Organization (CDMO) services. Monrol plans to make the site a center of excellence for both radiopharmaceutical production and scientific and industry collaborative efforts to create innovations. The facility is expected to be up and running by 2026 at an estimated cost of around 30 million euros. (*) Targeted radioligand therapy is an innovative approach to cancer treatment that is considered to
Fore Biotherapeutics Announces Fast Track Designation Granted by FDA to FORE8394 for the Treatment of Cancers Harboring BRAF Class 1 and Class 2 Alterations28.9.2022 15:00:00 CEST | Press release
Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to FORE8934, its investigational, novel, small-molecule, orally available inhibitor for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies. The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may become eligible for Accelerated Approval, Priority Review, or Rolling Review if relevant criteria are met. “The FDA's Fast Track Designation for FORE8394 underscores the urgent need faced by patients with advanced BRAF-muted cancers who have no other options,” said Stacie
Quectel Announces New SC680A LTE Smart Module to Drive Digital Transformation and Machine Vision AI Applications28.9.2022 15:00:00 CEST | Press release
Quectel Wireless Solutions, a global IoT solutions provider, today announces that it has released its new SC680A smart module which features broad connectivity options including LTE Cat 6, Wi-Fi 802.11ac and Bluetooth 5.0 with powerful system performance and rich multimedia functions. The SC680A smart module is targeted towards mid-tier IoT devices including POS and payment terminals, industrial handhelds for logistics and warehousing, in-vehicle infotainment and dashcam solutions as well as micro-mobility applications and small electric cars. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220928005031/en/ Quectel's new SC680A LTE smart module (Photo: Business Wire) “We are excited to introduce another highly integrated smart module which gives global customers more flexibility in their IoT device designs,” said Norbert Muhrer, President and CSO of Quectel. “It enables a variety of industrial and consumer IoT verticals with
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