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FDA Grants Priority Review to Enhertu for Metastatic HER2-Positive Solid Tumors

NEW YORK – Daiichi Sankyo and AstraZeneca on Monday said the US Food and Drug Administration granted priority review of their supplemental biologics license application for Enhertu (trastuzumab deruxtecan) as a second-line treatment for patients with unresectable or metastatic HER2-positive solid tumors.

The application is supported by data from the Phase II DESTINY-PanTumor02 trial in which the firms are evaluating treatment with Enhertu every three weeks in patients who have progressed following prior treatment or have no satisfactory alternative treatment option. In the ongoing trial, investigators have enrolled about 268 participants with HER2-positive biliary tract, bladder, cervical, endometrial, ovarian, and pancreatic cancers and rare tumors to receive Enhertu by intravenous infusion. They're tracking objective response rate as the primary outcome measure of the trial and secondary outcome measures including duration of response, disease control rate, progression-free survival, and overall survival.

The companies reported updated results from the trial at the European Society for Medical Oncology Congress in October. At a median follow-up time of nearly 13 months, 37.1 percent of patients had a confirmed objective response, and the overall response rate across tumor types was 37.5 percent, the median duration of response was 11.3 months, median progression-free survival was 6.9 months, and median overall survival was 13.4 months.

"The clinical benefit seen across HER2-expressing metastatic solid tumors in the DESTINY-PanTumor02 trial and ongoing data from the Enhertu clinical development program continues to demonstrate the potential of this medicine beyond its approved indications," Ken Takeshita, global head of R&D at Daiichi Sankyo said in a statement. "If approved, Enhertu could become the first HER2-directed therapy and antibody drug conjugate with a tumor-agnostic indication, providing patients with a potential new treatment option."

Enhertu has been approved in the US and Europe as a second-line therapy for patients with advanced non-small cell lung cancer harboring HER2 mutations.

A marketing application that the FDA is evaluating under priority review commits the agency to issuing a decision within six months as opposed to the 10 months the agency has for standard reviews. The agency is expected to make a decision on Enhertu by May 30.