On December 3, 2020 Genmab A/S (Nasdaq: GMAB) reported that Janssen Biotech, Inc. (Janssen) submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (U.S. 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 (Press release, Genmab, DEC 3, 2020, View Source [SID1234572123]). 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.
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"Today’s milestone underscores the promise of our DuoBody technology platform to effectively create innovative and truly differentiated bispecific antibody therapeutics," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
For more information related to Janssen’s amivantamab filing click here.
About Non-small Cell Lung Cancer
Lung cancer is the most common cancer worldwide. Approximately 80 to 85 percent of lung cancers are classified as NSCLC and include subtypes adenocarcinoma, squamous cell carcinoma and large cell carcinoma1,2. Mutations in the EGFR gene are common in patients with NSCLC, including 10 to 15 percent of NSCLC patients in Western countries.3,4 The five-year survival rate for all patients with metastatic NSCLC with EGFR mutations who are treated with EGFR tyrosine kinase inhibitors is less than 20 percent.5,6 In addition, the estimated median overall survival for patients with NSCLC and EGFR Exon 20 insertion mutations is shorted than in patients with common EGFR mutations.7