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
Mary Kay Awards Education Grant to Young Woman Aspiring to Become First Latin American Woman Astronaut to Visit Mars5.10.2022 23:40:00 CEST | Press release
As a decades-long leader in women’s empowerment and innovative science, Mary Kay celebrates young women who are taking charge of their futures through leadership, innovation, and determination to excel in STEAM fields. Women make up only 28% of the workforce in science, technology, engineering, and math.  By offering continued support to young women in STEAM fields, they are continuing Mary Kay’s mission, which is to improve women's lives everywhere. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221005005835/en/ Mary Kay is committed to inspiring young women making tremendous contributions to STEAM fields to continue to pursue their dream. (Photo: Mary Kay Inc.) “More young women gaining access to STEAM education leads to an increase in women embracing careers in those fields. In turn, this provides access to more equal opportunities for women, narrows the gender pay gap, bolsters economies, and eliminates bias in scient
300 Rimini Street Employees Will Gather in Las Vegas to Handmake 500 Fleece Blankets for Local Foster Children, Shelter Pets, and Homeless Youth5.10.2022 23:09:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that on October 6, 2022, over 300 Rimini Street employees gathered in Las Vegas will handmake 500 fleece blankets for local foster children. The blankets will then be donated to Clark County (Nev.) Department of Family Services and Foster Kinship, a Las Vegas-based non-profit. The volunteers will also craft 100 smaller blankets to be donated to the Las Vegas SPCA for animals waiting for their forever homes. The remaining fabric will be donated to volunteer quilters who sew garments for local homeless youth. The 500 blankets will be part of the supply package for recently appointed guardians to gift to the child upon arrival, helping them feel welcome during their critical adjustment phase. The fleece fabric used for the blankets is adorned with children’s characters and
Pyramid Analytics Formalizes US Federal Business Practice5.10.2022 21:04:00 CEST | Press release
Pyramid Analytics (Pyramid), a pioneering decision intelligence platform provider, today announced a new business practice dedicated to the specific needs of U.S. federal agencies. Led by a team of experts with a deep background in the federal market segment, Pyramid’s Federal Business Practice builds on the company’s success with federal agencies such as the U.S. Department of Veterans Affairs (VA) and strengthens its focus and commitment to providing the U.S. Federal Government and federal partners with sales, technical expertise, and services to deploy Decision Intelligence for strategic uses at scale. Key Points: Decision Intelligence enabled by AI and Machine Learning (ML) can modernize the delivery of critical public services, including healthcare, homeland security, and defense in the US federal market segment. President Biden’s Fiscal Year (FY) 2023 Budget proposes spending $65 billion on IT for civilian federal agencies and prioritizes IT Modernization, Cybersecurity, and Digi
Brijesh Jeevarathnam to Succeed Kelly Meldrum as Global Head of Fund Investments at Adams Street Partners5.10.2022 15:00:00 CEST | Press release
Adams Street Partners, LLC, a private markets investment firm with more than $50 billion of assets under management, announced today that Brijesh Jeevarathnam will be promoted to Partner & Global Head of Fund Investments. Jeevarathnam, who joined Adams Street as a Partner in Primary Investments in 2016, will also become a member of the firm’s Executive Committee as part of his new role. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221005005265/en/ Brijesh Jeevarathnam has been promoted to Partner & Global Head of Fund Investments of Adams Street Partners. (Photo: Business Wire) Jeevarathnam succeeds Kelly Meldrum, who is retiring after 17 years as a Partner & Head of Primary Investments at the firm. Meldrum will transition her duties at year-end and will make herself available through the end of Q1 2023. “Over her long tenure with Adams Street, Kelly has made innumerable contributions to the firm, not the least of which wa
NetWitness Launches White Hat Wednesdays Conversation Series5.10.2022 15:00:00 CEST | Press release
NetWitness: DATE & LOCATION: To register, visit the White Hat Wednesdays link here. Wednesday, October 19 at 11:30am ET Wednesday, November 16 at 11:30am ET More dates to be announced WHAT: NetWitness will be launching White Hat Wednesdays, a series of discussions exploring the latest cybersecurity threats enterprises face today, with the first session kicking off on October 19. Cybersecurity experts will share their personal experience regarding the evolution of today’s attacks and the steps incident response teams are taking to detect, mitigate, assess, and remedy these situations. The first topic will focus on threats to the financial industry and FIN13, a threat actor that targets this vertical. The discussion will include how these types of groups operate as well as what an attack on financial technology looks like. WHO: The following spokespeople and executives will be leading the discussions: Stefano Maccaglia, Practice Manager, NetWitness Incident Response Will Gragido, Head of
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