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:
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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.