Genmab announces that Janssen has received conditional European marketing authorization for RYBREVANT® (amivantamab) for patients with advanced non-small cell lung cancer with EGFR Exon 20 insertion mutations, after failure a platinum-based treatment

0


[ad_1]

Press release

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.

About Genmab
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.

Contact:
Marisol Peron, Senior Vice President, Global Investor Relations and Communications
T: +1 609 524 0065; E: [email protected]

For investor relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: [email protected]

This Press release contains forward-looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ significantly from future results or performance expressed or implied by such statements. Important factors that could cause our actual results or performance to differ materially include, but are not limited to, risks associated with preclinical and clinical product development, uncertainties associated with the results and conduct of clinical trials, including safety concerns. unforeseen events, uncertainties related to the product manufacturing, lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our industry and our markets, our inability to attract and to retain qualified personnel, the inapplicability or lack of protection of our patents and property rights, our relationships with affiliated entities, changes and technological developments that may make our products or technologies obsolete and other factors. For a more in-depth discussion of these risks, please refer to the sections on risk management in Genmab’s most recent financial reports, which are available at www.genmab.com and the risk factors included in Genmab the most recent annual report on Form 20-F and other files from the United States Securities and Exchange Commission (SEC), available at www.sec.gov. Genmab assumes no obligation to update or revise the forward-looking statements in this Press release nor to confirm such statements to reflect events or circumstances subsequent to the date made or compared to actual results, except as required by law.

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.

Press release n ° i15
CVR n ° 2102 3884
LEI code 529900MTJPDPE4MHJ122

Genmab A / S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

Attachment


[ad_2]

Share.

Comments are closed.