FDA Extends Review of AstraZeneca's Breast Cancer Drug Camizestrant
The FDA has extended its review of AstraZeneca's camizestrant, an oral selective estrogen receptor degrader (SERD), for the treatment of HR-positive, HER2-negative breast cancer with ESR1 mutations. This decision follows a previous advisory committee vote against the drug, citing insufficient evidence of clinical benefit. AstraZeneca has provided additional data, including analyses of circulating tumor DNA, to support its application. The extension allows the FDA to thoroughly evaluate these new findings, which could potentially strengthen the case for camizestrant's approval.