FDA Extends Review Period for AstraZeneca's Camizestrant NDA

The U.S. Food and Drug Administration has extended the review period for AstraZeneca’s new drug application for camizestrant, an investigational oral treatment for hormone receptor-positive breast cancer, the company said on May 27, 2026. The agency pushed back the Prescription Drug User Fee Act (PDUFA) target date by three months to review additional submitted data. Camizestrant is a next-generation oral selective estrogen receptor degrader (SERD). AstraZeneca did not disclose the new action date. The extension does not reflect concerns over the safety or efficacy of the drug, a spokesperson said. AstraZeneca is competing with Roche's giredestrant and other oral SERDs in a market aimed at replacing injectable therapies. The delay could impact the timing of a potential launch. AstraZeneca's U.S.-listed shares were little changed in early trading following the announcement.