On December 13, 2021 Genmab A/S (Nasdaq: GMAB) reported 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 (Press release, Genmab, DEC 13, 2021, View Source [SID1234596920]). 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.

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"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.