FDA Panel Votes Against AstraZeneca’s Breast Cancer Drug

AstraZeneca Plc failed to persuade a US regulatory review panel about the benefits of its novel breast cancer medicine, creating a hurdle for one of the key drugs in the company’s pipeline.

The Food and Drug Administration’s Oncology Drugs Advisory Committee voted against the medicine, finding it didn’t have a “meaningful benefit” for patients with a genetically-driven form of metastatic breast cancer whose disease hadn’t progressed while they were getting other treatment. Six members of the committee voted against it because they did not agree with the trial design and potential implications in the clinical setting.