The FDA gave Medivation and Astellas a boost by giving priority review to the partners’ application to expand the prostate cancer drug’s indication to include first-line status.
The drug is currently indicated for metastatic castration-resistant prostate cancer patients who have previously undergone chemotherapy and was approved in 2012.
PM Live notes that a pre-chemo indication will allow Medivation to provide early treatment competition for Janssen’s prostate cancer drug Zytiga, which lassoed the pre-chemo approval in July 2013.
