AstraZeneca (AZN) has been informed by the FDA that it will extend the PDUFA date to review additional data related to the New Drug Application for camizestrant.
The drug is being reviewed for use in combination with a cyclin-dependent kinase 4/6 inhibitor as a first-line treatment option.
The targeted patient group consists of those with hormone receptor-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation.
The extension follows a challenging advisory committee meeting held in April, where the FDA’s Oncologic Drugs Advisory Committee reviewed the application.
The committee did not reach a majority vote in favor of the benefit of switching to camizestrant in combination with a CDK4/6 inhibitor.
The committee’s assessment was based specifically on data from the SERENA-6 Phase III trial.
The vote concerned switching patients to camizestrant after detection of an ESR1 mutation in circulating tumor DNA prior to radiographic progression.
Following the advisory committee outcome, AstraZeneca provided additional analyses to the FDA in support of the application.
The FDA requested those additional analyses before the agency could continue its review of the submission.
At its last close, shares of AstraZeneca were trading at 13,960.0 pence, up 0.32%.
