FDA tags Bayer's prostate cancer drug for priority review as drugmaker gears up against rivals
Two months after Bayer and its Finnish partner Orion reported positive late-stage data for its prostate cancer drug darolutamide, the German drugmaker has convinced the FDA to grant priority review on its NDA.
Like Pfizer’s Xtandi and J&J’s Erleada, darolutamide is a non-steroidal androgen receptor inhibitor for prostate cancer patients whose disease has not spread but continues to grow despite low testosterone levels. But unlike the more entrenched drugs — both billed as potential blockbusters — Bayer says its drug has “inherently different pharmacokinetics,” leading to less CNS toxicity and lower risk for drug-drug interactions.
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