J&J Hopes To Reach Market First For Pre-Metastatic Prostate Cancer With Apalutamide
Janssen hasn’t released Phase III data yet but says the next-generation androgen receptor inhibitor showed potential benefit for metastasis-free survival.
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As generic competition to J&J's Zytiga starts to line up ahead of possible launches in October, Datamonitor Healthcare has been weighing up the prostate cancer therapy space and seeing where the future competition will come from for Pfizer and Astellas' market leader Xtandi.
J&J is hoping EU regulators will follow the US in fast-tracking the company’s prostate cancer franchise-extending drug apalutamide.
Patent Trial and Appeal Board finds that the patent covering the blockbuster prostate cancer drug is unpatentable, which could allow generics to launch at-risk in October once they obtain FDA approval; at least 12 firms have pending ANDAs.