JNJ 6372 filed with EMA for metastatic EGFR non-small cell lung cancer.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of JNJ 6372 (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 after failure of platinum-based chemotherapy. The application marks the first-ever regulatory submission in the EU for a treatment for patients with NSCLC that specifically targets EGFR exon 20 insertion mutations.The EMA submission for amivantamab is based on monotherapy data from the Phase I CHRYSALIS study, a multi-centre, open-label, multi-cohort study evaluating the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), in adult patients with advanced NSCLC. In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, as well as the safety profile of amivantamab. This data was also the basis of the submission of the Biologics License Application for amivantamab to the U.S. Food and Drug Administration (FDA) in December 2020. Early data about amivantamab as a monotherapy treatment in patients with NSCLC with EGFR exon 20 insertion mutations were presented at the American Society of Clinical Oncology (ASCO) 2020.