Genmab announces that Janssen has submitted a BLA to the FDA for amivantamab in non-small cell lung cancer.

Genmab A/S announced that Janssen Biotech, Inc. submitted a Biologics License Application (BLA) to the FDA seeking approval of amivantamab for the treatment of patients with 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. This is the first BLA submission for a product candidate that was created using Genmab’s proprietary DuoBody technology platform. In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific antibodies using Genmab’ s DuoBody technology platform. Patients with NSCLC and EGFR Exon 20 insertion mutations have a form of disease that is generally insensitive to approved EGFR TKI treatments and as a result carries a worse prognosis compared to patients with more common EGFR mutations (Exon 19 deletions/L858R substitution). The current standard of care for this patient population is conventional chemotherapy. Currently, there are no FDA-approved targeted therapies for patients with lung cancer who have EGFR Exon 20 insertion mutations. Estimated median overall survival for patients with NSCLC and Exon 20 insertion mutations is 16 months.