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AstraZeneca PLC on Friday said it had secured a recommendation for its cancer drug Truqap from US authorities, but failed to secure a majority in favour of its treatment camizestrant. Shares in the Cambridge-based pharmaceutical firm AstraZeneca fell 1.7% to 13,714.00 pence on Friday morning in London. AstraZeneca reported that the US Food & Drug Administration’s Oncologic Drugs Advisory Committee had voted seven-to-one in favour of Truqap, or capivasertib, combined with abiraterone and androgen deprivation therapy, to treat prostate cancer. The recommendation relates specifically to patients with PTEN-deficient metastatic hormone-sensitive prostate cancer. It was based on phase-three trial results, which linked the drug to a 19% reduction in the risk of radiographic disease progression or death, as well as ‘clinically meaningful improvement in median radiographic progression-free survival’. Susan Galbraith, AstraZeneca’s executive vice president of Oncology Haematology R&D, commented: ‘The committee’s recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the Truqap combination verifies its potential to address this significant need and optimise outcomes for patients’. Less positive for AstraZeneca was a vote on its breast cancer treatment camizestrant in combination with a CDK4/6 inhibitor. ODAC voted six-to-three against the drug. This means it did not secure the majority required for a recommendation as a first-line treatment for patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation. AstraZeneca noted: ‘The FDA is not bound by the committee’s guidance but takes its advice into consideration. AstraZeneca will continue to work with the FDA as it completes its review of the application.’ The FDA previously had granted camizestrant breakthrough status. Gailbraith said AstraZeneca was ‘disappointed’ by the outcome, and reaffirmed the company’s faith in camizestrant: ‘We remain confident in the clinical benefit the combination can bring to patients by changing therapeutic strategy at the earliest opportunity, and are committed to challenging the status quo in the pursuit of innovation that optimises outcomes for patients.’ Though camizestrant showed a 56% reduction in the risk of disease progression or death versus standard care in phase-three testing, data for the secondary endpoints such as time to second disease progression and overall survival were immature at the time of the analysis. ‘No new safety concerns were identified,’ AstraZeneca added. Regulatory applications for both camizestrant and Truqap are also under review in the EU. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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