On October 15, 2021 Genmab A/S (Nasdaq: GMAB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended the granting of a conditional marketing authorization in Europe for Janssen’s 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, OCT 15, 2021, View Source [SID1234591282]). 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 CHMP opinion for a product that was created using Genmab’s proprietary DuoBody technology platform.

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"Following the U.S. FDA approval of RYBREVANT earlier this year, we are extremely pleased that the CHMP has granted Janssen a positive opinion for amivantamab, the first such opinion for a product created using Genmab’s DuoBody technology platform. We are hopeful that this opinion will lead to an approval and to the first treatment option for European patients with advanced NSCLC with activating EGFR exon 20 insertion mutations," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

For more information related to Janssen’s CHMP opinion for amivantamab, click here.