Copenhagen, denmark, December 13 2021
The European Commission has granted Janssen-Cilag International SA (Janssen) VSconditional Mmarketing Aauthorization for RYBREVANT® (amivantamab) For the treatment of adult patients with Advanced non-small cell lung cancer with insertion mutations of exon 20 of the activating epidermal growth factor receptor after failure of platinum therapy.
Follows Ppositive ohpinion by the European Committee for Medicines for Human Use in October 2021
Represented Ffirst of all regulatory approval in Europea syndicate for a DuoBody® product
Genmab A / S (Nasdaq: GMAB) announced today that the European Commission (THIS) granted VSconditional Mmarketing Aauthorisation for Janssen RYBREVANT® (amivantamab), a fully human bispecific antibody, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activation of the epidermal growth factor receptor (EGFR) exon 20 insertion mutations after failure of platinum-based treatment. The approval follows a positive opinion from the European Medicines Agency (EMA) European Committee for Medicinal Products for Human Use (CHMP) in October 2021. In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab’s DuoBody technological platform. This is the first regulatory approval in the European Union for a product created using Genmab’s proprietary DuoBody technology platform.
“We are extremely pleased that with the latest approval from Janssen for RYBREVANT®, EU patients with advanced NSCLC with EGFR exon 20 insertion activating mutations may now have a new treatment option, ”said Jan van de Winkel, Ph.D. , CEO of Genmab. “As the first approval of a DuoBody product in the European Union, this also marks an important step in the validation of Genmab’s innovative DuoBody technology platform. “
For more information on the European approval of Janssen amivantamab, click on here.
Genmab is an international biotechnology company whose primary goal is to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data science, fueling multiple differentiated cancer treatments that impact people’s lives. To develop and deliver new therapies to patients, Genmab has formed more than 20 strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T cell activators, next-generation immune checkpoint modulators, enhanced effector-function antibodies, and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark, with sites in Utrecht, the Netherlands, Princeton, New Jersey, the United States and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.
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Genmab A / S and / or its subsidiaries own the following brands: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combinationwith the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. RYBREVANT® Iher J markOhnson & Johnson.
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