Janssen submitted a biologics license application to the FDA seeking approval of amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Janssen has 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.
The company also indicated it has established an expanded access program (NCT04599712) for patients in the US who may be eligible to obtain access to amivantamab during review of the BLA.
Importantly, this application marks the first ever regulatory submission for the treatment of this patient population.
“This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options,” Peter Lebowitz, MD, PhD, global therapeutic area head of Oncology at Janssen Research & Development, LLC, said in a press release. “We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programs.”
Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications.
The submission of the BLA for amivantamab is based on data from the monotherapy arm of the multi-center, open-label, multi-cohort, phase 1 CHRYSALIS study, which evaluated the safety and efficacy of amivantamab as a monotherapy and in combination with lazertinib in adult patients with advanced NSCLC. In the study, investigators evaluated efficacy using overall response rate per Response Evaluation Criteria in Solid Tumors Version 1.1, clinical benefit rate, duration of response, and progression-free survival, as well as the safety profile of amivantamab.
Of note, amivantamab previously received breakthrough therapy designation from the FDA for this population in March 2020.
Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations [news release]. Published December 3, 2020. Accessed December 3, 2020. https://www.morningstar.com/news/business-wire/20201203005243/janssen-submits-application-to-us-fda-seeking-approval-of-amivantamab-for-the-treatment-of-patients-with-metastatic-non-small-cell-lung-cancer-with-egfr-exon-20-insertion-mutations