Rybrevant godkendelse

105603 Bulder 25/8 2022 13:57

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 of Platinum-base
Media Release

Copenhagen, Denmark, December 13, 2021
• The European Commission has granted Janssen-Cilag International NV (Janssen) Conditional Marketing Authorization for RYBREVANT® (amivantamab) for the treatment of adult patients with advanced non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations, after failure of platinum-based therapy.
• Follows Positive Opinion by the European Committee for Medicinal Products for Human Use in October 2021
• Represents first regulatory approval in European Union for a DuoBody® product

Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted Conditional Marketing Authorization for Janssen's RYBREVANT® (amivantamab), a fully human bispecific antibody, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy. The approval follows a Positive Opinion by the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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 technology platform. This is the first regulatory approval in the European Union for a product that was created using Genmab's proprietary DuoBody technology platform.
"We are extremely pleased that, with Janssen's latest approval for RYBREVANT®, patients in the EU with advanced NSCLC with activating EGFR exon 20 insertion mutations may now have a new treatment option," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "As the first approval for a DuoBody product in the European Union, this also marks an important milestone in the validation of Genmab's innovative DuoBody technology platform."
For more information related to the European approval of Janssen's amivantamab click here.
About Genmab
Genmab is an international biotechnology company with a core purpose 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 sciences, fueling multiple differentiated cancer treatments that make an impact on people's lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab's proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. 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 & Communications
T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Media 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 materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. RYBREVANT® is a trademark of Johnson & Johnson.

Media Release no. i15
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
• 131221_i15_RYBREVANT EU approval

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