J&J’s Zytiga Secures Survival Claim For Early Metastatic Prostate Cancer
This article was originally published in The Pink Sheet Daily
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.
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Bullish analysts predicted Xtandi easily wins over first-to-market Zytiga in pre-chemo prostate cancer, based on PREVAIL findings. But in the formal presentation at the ASCO GU meeting, clinicians were more reluctant to compare the two drugs and took a more nuanced interpretation of the data, given the important differences in study designs.
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.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.