On May 21, 2021 Genmab A/S (Nasdaq: GMAB) reported 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 (Press release, Genmab, MAY 21, 2021, View Source [SID1234580439]). 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.
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"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."