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Janssen Submits Application to FDA for EGFR-Mutated Lung Cancer Treatment

NEW YORK – Janssen Pharmaceutical said it submitted a biologics license application (BLA) to the US Food and Drug Administration on Thursday for amivantamab to treat non-small cell lung cancer patients with EGFR exon 20 mutations.

The BLA submission for the EGFR-MET bispecific antibody includes data from the Phase I CHRYSALIS study. Patients in that trial experienced an overall response rate of 36 percent and a median progression-free survival of 8.3 months. Patients who had received prior treatment with platinum-based chemotherapy experienced slightly better outcomes in this study, with a 41 percent overall response rate and median progression-free survival of 8.6 months.

Previous research has found that exon 20 mutations characterize between 2 percent and 10 percent of EGFR-mutated tumors. Patients with these tumor mutations also typically have poorer outcomes than other NSCLS patients, with a median survival of less than 17 months.

EGFR exon 20 mutations may be detected by next-generation sequencing, and in a statement announcing the submission, Janssen noted that companion diagnostics to identify lung cancer patients with these mutations have been integral to the amivantamab development program. In July, Janssen inked a deal with Guardant Health to pursue regulatory approval and commercialization of a companion diagnostic for the drug using the 74-gene Guardant360 blood-based NGS test.

Janssen's amivantamab BLA is the first regulatory submission for a NSCLC treatment targeting EGFR exon 20 insertion mutations. "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, global therapeutic area head for oncology for Janssen Research & Development, said in a statement.

In March, Janssen received breakthrough therapy designation for amivantamab. While the BLA is under review, Janssen has set up an expanded access program to help patients receive the drug.