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(Alliance News) - AstraZeneca PLC on Friday said the US Food & Drug Administration's Oncologic Drugs Advisory Committee has recognised a favourable benefit risk profile for its Lynparza, plus abiraterone and prednisone or prednisolone, for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer.
The pharmaceutical firm said the recognition was based on the PROpel phase three trial, with the committee voting eleven to one - with one abstaining - that the indication should be limited to patients whose tumours have a BRCA mutation.
Lynparza is being jointly developed and commercialised by AstraZeneca and Merck & Co Inc. It is a PARP inhibitor and a targeted treatment to block DNA damage response.
The ODAC provides the US FDA with independent advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The US FDA is not bound by the committee's guidance but takes its advice into consideration, AstraZeneca explained.
Susan Galbraith, executive vice president of Oncology Research & Development at AstraZenca said: "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. 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."
By Heather Rydings, Alliance News senior economics reporter
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