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™ 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].
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220817005324/en/
Contact information
Holly Barber
hbarber@hanovercomms.com
+44 (0) 07759 301620
Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
“e4life” is Present at Expomed Eurasia with its Innovative Device Able to Inactivate Flu and Covid Viruses With an Efficacy over 90%19.4.2024 18:13:00 EEST | Press release
Expomed Eurasia, the most important medical exhibition between Europe and Asia, is ready to house more than a hundred companies, to discover new technological trends and the most innovative products which are going to change deeply the health market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240419226980/en/ e4life: e4ambient and e4you devices (Photo: Business Wire) This is a perfect occasion for e4life to present its device based on the e4shield technology which is able to inactivate flu and Covid viruses present in the air. A technology, patented in Italy, that uses neither chemical agents nor filtering materials, but it is based on the transmission of electromagnetic waves able to inactivate the viral load in aerosol. “This Exhibition represents an extraordinary opportunity to present our innovative technology (e4shield) in a dynamic and rapidly evolving region as Eurasia. In a climate of growing consciousness of the
Qualcomm Schedules Second Quarter Fiscal 2024 Earnings Release and Conference Call19.4.2024 16:00:00 EEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced that it will publish the Company’s financial results for its second quarter fiscal 2024 on Wednesday, May 1, 2024, after the close of the market on the Company’s Investor Relations website, at https://investor.qualcomm.com/financial-information. The earnings release will also be furnished to the Securities and Exchange Commission (SEC) on a Form 8-K, which will be available on the SEC website at http://www.sec.gov. Qualcomm will host a conference call to discuss its second quarter fiscal 2024 results which will be broadcast live on May 1, 2024, beginning at 1:45 p.m. Pacific Time (PT) at https://investor.qualcomm.com/news-events/events. An audio replay will be available at https://investor.qualcomm.com/news-events/events and via telephone following the live call for 30 days thereafter. To listen to the replay via telephone, U.S. callers may dial (877) 660-6853 and international callers may dial (201) 612-7415. Callers should use rese
Newmont Appoints Mining Industry Veteran Francois Hardy as Chief Technology Officer19.4.2024 15:56:00 EEST | Press release
Newmont Corporation (NYSE: NEM, TSX: NGT, ASX: NEM, PNGX: NEM) today announced the appointment of Francois Hardy as Chief Technology Officer (CTO). Francois will join Newmont’s Executive Leadership Team and lead the technical work across the business to improve operational performance and drive growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240419973025/en/ Newmont Appoints Mining Industry Veteran Francois Hardy as Chief Technology Officer (Photo: Business Wire) Francois will take over from interim CTO, Dean Gehring, who also served in a dual role as Newmont’s Chief Integration Officer. After a period of transition, Dean will be leaving the company in early July. Francois brings more than 30 years of technical and operational experience in mining to the role. He commenced with Newmont in 2002 and has held roles including Group Head Exploration, Managing Director Africa and General Manager Tanami. “Francois is a stron
SLB Announces First-Quarter 2024 Results, Targeting to Return $7 Billion to Shareholders Over 2024–202519.4.2024 13:50:00 EEST | Press release
SLB (NYSE: SLB) today announced results for the first-quarter 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240417469361/en/ The exterior of the SLB headquarters in Houston, Texas (Photo: Business Wire) First-Quarter Results (Stated in millions, except per share amounts) Three Months Ended Change Mar. 31, 2024 Dec. 31, 2023 Mar. 31, 2023 Sequential Year-on-year Revenue $8,707 $8,990 $7,736 -3% 13% Income before taxes - GAAP basis $1,357 $1,433 $1,161 -5% 17% Income before taxes margin - GAAP basis 15.6% 15.9% 15.0% -35 bps 58 bps Net income attributable to SLB - GAAP basis $1,068 $1,113 $934 -4% 14% Diluted EPS - GAAP basis $0.74 $0.77 $0.65 -4% 14% Adjusted EBITDA* $2,057 $2,277 $1,788 -10% 15% Adjusted EBITDA margin* 23.6% 25.3% 23.1% -171 bps 51 bps Pretax segment operating income* $1,649 $1,868 $1,391 -12% 19% Pretax segment operating margin* 18.9% 20.8% 18.0% -184 bps 95 bps Net income attributable to SLB, exclud
Zayo Group Appoints New CEO of Zayo Europe19.4.2024 10:00:00 EEST | Press release
Zayo Group, a leading global provider of network infrastructure, has appointed Colman Deegan as its new CEO of Zayo Europe to drive the business’ growth as cloud and AI adoption continues across the continent. This appointment is effective as of April 16, 2024. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240419471253/en/ Colman Deegan, CEO Zayo Europe (Photo: Business Wire) Steve Smith, CEO Zayo Group, says, “Colman’s experience and proven track record as a CEO leading large teams and businesses makes him perfectly equipped to take our European business to new heights, together with our outstanding local team. Colman will drive Zayo forward, strengthening our partnerships with data centres, hyperscalers, and enterprises across Europe. Under Colman’s leadership, we are confident that we will achieve our bold ambitions and maximise our impact in the European market.” Deegan spent more than two decades at Vodafone where he h
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