Can Zytiga Prevail In Pre-Chemo Prostate Cancer Without Proof Of Survival Benefit?
J&J’s abiraterone gains FDA clearance for the new claim without statistical significance for its 5-month survival advantage, but Medivation’s Xtandi is waiting in the wings – and its pre-chemo trial, PREVAIL, is likely to show a significant effect.
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Labeling now indicates a statistically significant 19% reduction in risk of death for Zytiga in chemo-naïve metastatic prostate cancer, similar to the 23% reduction just reported in long-term analysis of Medivation/Astellas’ competing Xtandi in the same population.
Using anonymous examples at the recent AACR meeting, FDA’s Tatiana Prowell highlights mistakes made and lessons learned in oncology drug reviews.
The oncology drug has been submitted for approval in the larger chemotherapy-naïve patient population and Medivation intends to increase its sales force to support the launch.