AstraZeneca (AZN,AZN.L) announced that the US Food and Drug Administration or FDA will extend the PDUFA date to review additional data requested to support the New Drug Application or NDA for Camizestrant in combination with a cyclin-dependent kinase 4/6 inhibitor for the first-line treatment of patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation.
Camizestrant is an investigational, oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer.
The NDA submission was based on positive results from the pivotal SERENA-6 Phase III trial, which evaluated the efficacy and safety of Camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) versus treatment with an AI (anastrozole or letrozole) in combination with palbociclib, ribociclib or abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.
According to the report, 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 III trial.
Following that, the firm has provided additional analyses requested by the FDA in support of the application, including ctDNA clearance data linked to longer-term efficacy outcomes.
"We look forward to continuing the dialogue with the FDA in order to bring the benefits of Camizestrant with this innovative treatment strategy to eligible patients in the US as quickly as possible," said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said,
Camizestrant is approved in the United Arab Emirates and Saudi Arabia, and regulatory applications are under review in Japan and other countries, based on data from the SERENA-6 Phase III trial.
Notably, last week, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of the Camizestrant combination in this setting, based on the results of the SERENA-6 Phase III trial.
AZN has traded between $137.22 and $212.71 over the last year. The stock closed Tuesday's trade at $187.19, up 0.09%.
In the pre-market, AZN is down 0.35% at $186.50.
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