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The US Food and Drug Administration has fast-tracked Bayer’s investigational compound Alpharadin™ for the treatment of castration-resistant (hormone refractory) prostate cancer in patients with bone metastases.
Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee said: “We are excited that Alpharadin has achieved this important milestone and recognise this fast track designation as an important step in the overall development of Alpharadin, particularly for those patients in need of treatment.”
In June, Bayer announced that the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial evaluating Alpharadin in patients with CRPC and symptomatic bone metastases met its primary endpoint by significantly improving overall survival.
Based on a recommendation from the Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis, the study was stopped and patients on the placebo arm have been offered treatment with Alpharadin.
The overall survival result was statistically significant (two-sided p-value=0.0022, hazard ratio=0.699). Median overall survival was 14.0 months for Alpharadin and 11.2 months for placebo.
The safety and tolerability of Alpharadin were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of Alpharadin. The complete results from the study will be presented at an upcoming scientific meeting.
Fast-Track designation in the United States is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need.
Fast Track addresses a broad range of serious diseases. Fast Track designation must be requested by the drug company and can be initiated at any time during the drug development process.
Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.