UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for Enhertu (trastuzumab deruxtecan), submitted in partnership with Japan’s Daiichi Sankyo (TYO: 4568) to the US Food and Drug Administration (FDA), has been granted priority review. The treatment is now under consideration for unresectable or metastatic HER2-positive solid tumors in adults who have received prior treatment or have no alternative options. The FDA anticipates making a decision during the second quarter of 2024 through its real-time oncology review (RTOR) program.
The submission is backed by interim results from an ongoing Phase II trial, which demonstrate that the HER2-directed antibody drug conjugate (ADC) provides durable responses and significant survival benefits in patients with various solid tumors, including biliary tract, bladder, cervical, endometrial, and ovarian cancers. The safety profile of the drug remains consistent with previous observations.
Enhertu has the potential to be the first anti-HER2 therapy and ADC to receive a tumor-agnostic indication, marking a significant advancement in targeted cancer treatments.- Flcube.com
