FDA Extends Review of AstraZeneca’s Camizestrant After Advisory Committee Vote

On May 27 the FDA extended the decision deadline for AstraZeneca’s oral selective estrogen receptor degrader camizestrant. The extension follows a six-to-three ODAC vote in April that found data for camizestrant with a CDK4/6 inhibitor inconclusive. The agency asked for additional circulating tumor DNA (ctDNA) clearance analyses, which AstraZeneca will present at the American Society of Clinical Oncology (ASCO) meeting on June 2.

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Camizestrant is the fourth oral selective estrogen receptor degrader (SERD) in development, targeting HR-positive, HER2-negative breast cancers with ESR1 mutations. In the SERENA-6 trial, switching to camizestrant cut disease progression or death by 56 % versus continued hormone therapy. The European Medicines Agency’s CHMP recently recommended approval, and the drug is already authorized in the United Arab Emirates and Saudi Arabia.

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The ODAC vote was 6-3 against the indication. AstraZeneca projects camizestrant could generate over $5 billion in annual sales, supporting its $80 billion revenue goal by 2030. Two oral SERDs—elacestrant and inmulestrant—are already approved in the U.S. for second-line use.

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AstraZeneca reiterated its commitment to work with the FDA, noting that the submitted ctDNA analyses address the request for data linked to longer-term efficacy. The company highlighted the SERENA-6 strategy of monitoring ESR1 mutations to guide therapy switches and pledged to bring camizestrant to patients quickly.

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Breast-cancer specialists surveyed by Leerink Partners said they are skeptical that sufficient data have been generated to merit the regimen’s use. They also cite the ODAC-raised trial-design concerns as a barrier to a frontline indication.

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The FDA advisory panel found the evidence inconclusive, while the EMA’s CHMP recommended approval, creating divergent assessments. The FDA has not disclosed the extension length or a target decision date, leaving the U.S. timeline uncertain.

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AstraZeneca will present the ctDNA data at ASCO on June 2. SERENA-4, enrolling an all-comer HR-positive cohort regardless of ESR1 status, is slated for results later in 2026 and could support a first-line indication.

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• “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.” — Susan Galbraith, Head of Oncology and Haematology R&D, AstraZeneca

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• “We are committed to continuously advancing the clinical landscape in oncology in pursuit of improving outcomes for patients,” — Susan Galbraith, AstraZeneca

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• “sufficient data generated to merit the regimen's use.” — Andrew Berens, Analyst, Leerink Partners

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• “ctDNA clearance data linked to longer-term efficacy outcomes,” — FDA request (as quoted in AstraZeneca statement)

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