AstraZeneca (AZN,AZN.L,ZEG.DE,AZN.ST) said the FDA has informed that it will extend the PDUFA date to review additional data requested to support the New Drug Application for camizestrant in combination with a cyclin-dependent kinase 4/6 inhibitor for the 1st-line treatment of patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation.
In April, 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 prior to radiographic progression, based on the SERENA-6 Phase III trial. Subsequently, the company has provided additional analyses requested by the FDA in support of the application.
At last close, shares of AstraZeneca were trading at 13,960.0 pence, up 0.32%.
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