FDA Grants Accelerated Approval to Enhertu for HER2-Mutant NSCLC

The FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) in adult patients with unresectable or metastatic nonsmall-cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations and who have received a prior systemic therapy.

The approval was based on clinical trial results that showed the drug’s efficacy, with an objective response rate of 58 percent and a median duration of response of 8.7 months.

Continued approval for the indication may be contingent upon verification of clinical benefit in a confirmatory trial, the FDA said.

Enhertu is the first drug the agency has approved for HER2-mutant NSCLC.