“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and this filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology.“We are encouraged by the FDA’s decision to grant priority review to the Rubraca application, which focuses on eligible patients with advanced prostate cancer, for whom new treatment options are very much needed.”
A priority review designation is granted to proposed medicines that the FDA has determined have the potential, if approved, to offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. Priority designation shortens the review period from the standard 10 months to six months.
Source: "Clovis Oncology’S Rubraca® (Rucaparib) Granted FDA Priority Review For Advanced Prostate Cancer". 2020. Ir.Clovisoncology.Com.
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