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Genmab Announces that Janssen has been Granted U.S. FDA Approval for RYBREVANT™ (amivantamab-vmjw) for Patients with Metastatic Non-small Cell Lung Cancer with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations

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Media Release

Copenhagen, Denmark, May 21, 2021

  • Janssen Biotech, Inc. (Janssen) received U.S. FDA approval for RYBREVANT(amivantamab-vmjw) for patients with metastatic non-small cell lung cancer with epidermal growth factor receptor Exon 20 insertion mutations

  • First regulatory approval for a DuoBody® product candidate


Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved Janssen’s RYBREVANT(amivantamab-vmjw), a fully human bispecific antibody, for the treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. This is the first regulatory approval for a product that was created using Genmab’s proprietary DuoBody® technology platform. Under the agreement with Janssen, Genmab will receive royalties on net sales of RYBREVANT.

“The U.S. FDA approval of Janssen’s RYBREVANT is a significant milestone as it represents the first regulatory approval for a therapeutic product created using Genmab’s DuoBody technology platform. As described in a recent Journal of Biological Chemistry article, the creation of amivantamab was a team effort between Janssen R&D and Genmab,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “With this approval this innovative bispecific antibody has become a promising new therapy for certain NSCLC patients. We hope this is the first validation out of many of the major potential of our innovative DuoBody technology platform to create truly differentiated bispecific antibody therapeutics.”

For more information related to the U.S. FDA approval of Janssen’s RYBREVANT, including indication, click here.

About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients with cancer. Founded in 1999, Genmab is the creator of multiple approved antibody therapeutics that are marketed by its partners. The company aims to create, develop and commercialize differentiated therapies by leveraging next-generation antibody technologies, expertise in antibody biology, translational research and data sciences and strategic partnerships. To create novel therapies, Genmab utilizes its next-generation antibody technologies, which are the result of its collaborative company culture and a deep passion for innovation. Genmab’s proprietary pipeline consists of modified antibody candidates, including bispecific T-cell engagers and next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. The company 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.

Contact:
Marisol Peron, Senior Vice President, Global Investor Relations & Communications
T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:
Andrew Carlsen, Senior Director, 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. 06
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

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