22 January 2020 - - The US Food and Drug Administration has accepted US-based biopharmaceutical company Clovis Oncology, Inc.'s (NASDAQ: CLVS) supplemental New Drug Application for Rubraca (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020.

Clovis submitted the sNDA submission for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.

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.

The American Cancer Society estimated that more than 175,000 men in the United States would be diagnosed with prostate cancer in 2019, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 450,000 men in Europe were diagnosed with prostate cancer in 2018.

Castrate-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castrate-resistant prostate cancer, or mCRPC, is an incurable disease, usually associated with poor prognosis.

Approximately 43,000 men in the US are expected to be diagnosed with mCRPC in 2020.

According to the American Cancer Society, the five-year survival rate for mCRPC is approximately 30%.

Up to 12 % of patients with mCRPC harbor a deleterious germline and/or somatic mutation in the genes BRCA1 and BRCA2. These molecular markers may be used to select patients for treatment with a PARP inhibitor.

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Myelodysplastic Syndrome /Acute Myeloid Leukemia occur uncommonly in patients treated with Rubraca, and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients, including those in long-term follow-up.

Of these, five occurred during treatment or during the 28-day safety follow-up. The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months.

The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA-damaging agents.

Clovis Oncology is a biopharmaceutical company focused on acquiring, developing and commercialising innovative anti-cancer agents in the US, Europe and additional international markets.