FDA Updates: Approval Sought in Metastatic NSCLC; More Time Needed for Balstilimab

Amivantamab filing for Janssen. On Friday, Janssen announced it had submitted a biologics license application (BLA) seeking FDA approval for amivantamab for the treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations and disease progression, for patients who are on chemotherapy or have concluded platinum-based chemotherapy. Animvantamab is a bispecific antibody that targets both EGFR, which are very common in NSCLC, as well as mesenchymal epithelial transition (MET) factor. Submission is based on results from the phase I CHRYSALIS trial, which were presented at the American Society of Clinical Oncology virtual program in May. Findings showed a 36% overall response rate, including a 41% response rate in patients who had previously received platinum-based chemotherapy. Data from the trial also support creation of an expanded access program, allowing some patients to be treated while FDA weighs approval of the BLA.

Balstilimab BLA filing to be completed in early 2021. On Thursday, Agenus announced an updated timeline for submitting feedback that FDA seeks to complete its BLA filing for balstilimab, an investigational immunotherapy to treat recurrent or metastatic cervical cancer. FDA requires feedback on all patients for a median of 12 months and responders for a minimum of 6 months. Additional follow-up is now required to present data on 2 patients who experienced duration stabilization and “converted to confirmed responses on long-term balstilimab therapy,” the company said in a statement.