FDA Grants Priority Review to Rucaparib for BRCA1/2-Positive mCRPC


The FDA granted priority review to rucaparib for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer.

The FDA granted priority review to rucaparib (Rubraca) for the treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castration-resistant prostate cancer (mCRPC), according to Clovis Oncology, the drug’s manufacturer.1

The agency set a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020.

The application is based on findings from the ongoing, international, multicenter, open-label phase II TRITON2 trial that enrolled male patients with mCRPC associated with 1 of 13 homologous recombination repair (HRR) gene alterations.

Patients were treated with rucaparib at 600 mg twice daily until radiographic progression or treatment discontinuation.

The primary endpoints of the trial include confirmed ORR per RECIST/Prostate Cancer Clinical Trials Working Group 3 criteria in patients with measurable disease at baseline and PSA response in patients with no measurable disease at baseline.

Patients treated with the PARP inhibitor induced a 43.9% confirmed objective response rate (ORR; 95% CI, 24.4%-65.1%) by investigator assessment in 57 RECIST—evaluable patients with BRCA1/2-mutant mCRPC. Among those with BRCA1/2 alterations, 51.1% had a confirmed PSA response to rucaparib. All 11 investigator-assessed radiographic responses in the patients with BRCA-mutated tumors were partial responses (PRs); 9 patients (36.0%) had stable disease. The median duration of response had not been reached.

The most common any-grade treatment-emergent adverse events occurring in >20% of patients were asthenia/fatigue (55.3%), nausea (49.5%), anemia/decreased hemoglobin (37.9%), decreased appetite (27.9%), transient increased aspartate transaminase/alanine aminotransferase (24.7%), constipation (24.7%), vomiting (22.1%), and diarrhea (21.1%).

Updated findings from the trial were presented at the 2019 ESMO Congress in September.2

“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,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release. “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.”


1. Clovis Oncology’s Rubraca (rucaparib) granted FDA priority review for advanced prostate cancer [news release]: Boulder, CO. Clovis Oncology, Inc. Published January 15, 2020. https://ir.clovisoncology.com/investors-and-news/news-releases/press-release-details/2020/Clovis-Oncologys-Rubraca-rucaparib-Granted-FDA-Priority-Review-for-Advanced-Prostate-Cancer/default.aspx. Accessed January 15, 2020.

2. Clovis Oncology highlights Rubraca (rucaparib) updated data from the ongoing TRITON2 clinical trial in patients with mCRPC and exploratory and integrated analyses in recurrent ovarian cancer at the ESMO Congress 2019 [news release]: Boulder, CO. Clovis Oncology, Inc. Published September 29, 2019. https://ir.clovisoncology.com/investors-and-news/news-releases/press-release-details/2019/Clovis-Oncology-Highlights-Rubraca-rucaparib-Updated-Data-from-the-Ongoing-TRITON2-Clinical-Trial-in-Patients-with-mCRPC-and-Exploratory-and-Integrated-Analyses-in-Recurrent-Ovarian-Cancer-at-the-ESMO-Congress-2019/default.aspx. Accessed January 15, 2020.

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