The FDA has notified AstraZeneca that it will be extending the PDUFA date for the company’s camizestrant combination, citing a need to review additional data to support the NDA.
The NDA is for camizestrant with a cyclin-dependent kinase (CDK) 4/6 inhibitor — either plabociclib, ribociclib, or abemaciclib. It is a first-line treatment for patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer with an emergent ESR1 mutation.
Although the SERENA-6 phase 3 trial showed positive results for the drug, the FDA’s Oncologic Drugs Advisory Committee (ODAC) failed to reach a majority vote in favor of the benefit–risk profile. AstraZeneca has since given the FDA additional analyses to support its application, such as ctDNA clearance data demonstrating longer-term efficacy.