J&J’s Rybrevant Wins FDA Approval for Nonsmall-Cell Lung Cancer with Mutation

For the first time, the FDA has approved a treatment for adult nonsmall-cell lung cancer (NSCLC) patients with a specific type of genetic mutation, giving Johnson & Johnson’s (J&J) Rybrevant the green light.

Specifically, the agency approved J&J subsidiary Janssen’s Rybrevant (amivantamab-vmjw) for adult NSCLC patients whose tumors have epidermal growth-factor receptor exon 20 insertion mutations. The approval also marks J&J’s first for a lung cancer treatment.

The approval was supported by a study enrolling 81 patients whose disease had progressed during or after treatment with platinum-based chemotherapy, the FDA said. Patients given the bispecific antibody demonstrated an overall response rate of 40 percent, with 63 percent of them showing a response that lasted six months or longer.