AstraZeneca and Daiichi Sankyo's Enhertu is on fire with two key FDA approvals in as many weeks.
Friday, the drug scored an accelerated approval in patients with HER2-mutant non-small cell lung cancer (NSCLC) who have received a prior systemic therapy. With the nod, the HER2-directed antibody drug conjugate becomes the first drug specifically approved for HER2-mutant NSCLC, the FDA says.
The agency based its latest Enhertu approval on results from the DESTINY-Lung02 trial. In the study, 57.7% of patients with previously treated unresectable or metastatic non-squamous HER2-mutant NSCLC responded to the therapy at an interim assessment.
Since this is an accelerated approval, Enhertu's continued licensure in the disease may be contingent on the drug proving itself in a confirmatory trial, AZ notes.
Along with the nod, the FDA signed off on companion diagnostics that can detect HER2 mutations in patients with lung cancer.
Aside from its lung cancer nod, Enhertu has been approved in breast and gastric cancers.
Friday's FDA nod comes a week after Enhertu's groundbreaking approval in HER2-low unresectable or metastatic breast cancer. With that approval, which came four months ahead of schedule, the drug inaugurated an entirely new category of treatment.