US regulators have accepted Clovis Oncology’s supplemental New Drug Application (sNDA) for Rubraca (rucaparib) and granted priority review.
The sNDA was submitted for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.
“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients withBRCA1/2-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.”
The FDA has assigned a Prescription Drug User Fee Act date of May 15, 2020.