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AstraZeneca PLC on Tuesday bemoaned the results of a regulatory meeting held by the US Food & Drug Administration, which suggested its Lynparza prostate cancer treatment should be limited to tumours with a BRCA mutation. The US FDA’s Oncologic Drugs Advisory Committee recognised a favourable benefit risk profile for AstraZeneca and MSD’s Lynparza plus abiraterone and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer. Its judgement was based on the PROpel Phase III trial. ODAC voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation. Though the FDA is not bound by ODAC’s guidance, it does take its advice into consideration. Astra told investors it would continue to work with the FDA as it completes its review of the application. ‘Novel treatment options are urgently needed for patients with metastatic castration-resistant prostate cancer. While we are pleased with the recognition of the benefit of Lynparza plus abiraterone for patients with BRCA-mutated metastatic castration-resistant prostate cancer, we are disappointed with the outcome of today’s ODAC meeting,’ said Susan Galbraith, executive vice president of oncology research and development at Astra. She added: ‘We strongly believe in the results of the PROpel trial, which demonstrated the clinically meaningful benefit for this combination in a broad population of patients regardless of biomarker status’. Results from the PROpel trial showed a statistically significant and clinically meaningful 34% reduction in the risk of radiographic disease progression or death with Lynparza. AstraZeneca shares were trading 0.3% higher at 11,784.00 pence each in London on Tuesday morning. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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