Posted by Michael Wonder on 27 May 2026
US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data
27 May 2026 - The US FDA has informed AstraZeneca that it will extend the PDUFA date to review additional data requested to support the n ew drug application for camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the first-line treatment of patients with hormone receptor positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation.
In April 2026, the FDA's Oncologic Drugs Advisory Committee did not reach a majority vote in favour of the benefit of switching to camizestrant in combination with a CDK4/6 inhibitor after detection of an ESR1 mutation in circulating tumour DNA (ctDNA) prior to radiographic progression, based on the SERENA-6 Phase 3 trial. Subsequently, the Company has provided additional analyses requested by the FDA in support of the application, including ctDNA clearance data linked to longer-term efficacy outcomes that will be presented on 02 June at ASCO 2026.
