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 factorGenmab 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.”

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