The FDA has granted priority review status on a supplemental New Drug Application for rucaparib in advanced prostate cancer, according to a release issued by Clovis Oncology.1 The sNDA seeks approval for rucaparib as monotherapy treatment in patients with a BRCA1/2 mutation resulting in recurrent metastatic castrate-resistant prostate cancer. The agency has assigned a Prescription Drug User Fee Act date of May 15, 2020.
The FDA has granted priority review status on a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) in advanced prostate cancer, according to a release issued by Clovis Oncology.1The sNDA seeks approval for rucaparib as monotherapy treatment in patients with aBRCA1/2mutation resulting in recurrent metastatic castrate-resistant prostate cancer. The agency has assigned a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020.
The basis for the sNDA is the open-label TRITON3 trial (NCT02975934).2Investigators will determine how patients with metastatic castration-resistant prostate cancer and aBRCA1/2mutation will respond to rucaparib versus treatment with physician’s choice of abiraterone acetate (Zytiga), enzalutamide (Xtandi), or docetaxel. The primary end point is radiographic progression-free survival (rPFS) and secondary end points include objective response rate (ORR), duration of response (DOR), and time to prostate-specific antigen progression.
“Recently presented data suggest 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,” Patrick J. Mahaffy, president and CEO of Clovis Oncology said in a statement. “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 6 months.
Previously, rucaparib received breakthrough therapy designation from the FDA for single-agent use in adult patients withBRCA1/2-positive metastatic castration-resistant prostate cancer (mCRPC) following at least 1 androgen receptordirected therapy and taxane-based chemotherapy.3That decision was based on the phase II TRITON2 study in patients with advanced prostate cancer (NCT02952534).
Rucaparib, an oral, small molecule inhibitor of PARP1, PARP2, and PARP3 is indicated for maintenance treatment in recurrent epithelial ovarian, fallopian, or primary peritoneal cancer in patients who are in a complete or partial response to platinum-based chemotherapy. The agent is also indicated in patients with deleterious BRCA mutations associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 2 or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for rucaparib, FoundationFocus CDxBRCA.
Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer [news release]. Boulder, Colorado: Clovis Oncology; January 15, 2020.https://bit.ly/2RfG4da. Accessed January 15, 2020.