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FDA grants breakthrough therapy designation to Rubraca for prostate cancer
The FDA granted rucaparib breakthrough therapy designation for the treatment of patients with BRCA1/BRCA2-mutated, metastatic, castration-resistant prostate cancer, according to the manufacturer.
This designation applies to patients who have received at least one prior androgen receptor-directed therapy and taxane-based chemotherapy.
The FDA based this designation on results from the TRITON2 study, which assessed rucaparib (Rubraca, Clovis Oncology) among patients with advanced prostate cancer with BRCA1/BRCA2 mutations and deleterious mutations of other homologous recombination repair genes.
“We are committed to the rapid development of Rubraca in metastatic, castration-resistant prostate cancer and we are obviously pleased to receive breakthrough therapy designation. We look forward to presenting the data that served as the basis of our breakthrough therapy designation application at the ESMO [Congress] later this month,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a company-issued press release. “We hope the decision by the FDA to grant this breakthrough therapy designation for Rubraca offers encouragement to the prostate cancer community, and we will do our best to make Rubraca available to eligible prostate cancer patients as quickly as possible.”
Rucaparib is an oral, small molecule PARP inhibitor. Itis indicated for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, as well as for treatment of certain adults with deleterious BRCA mutations associated epithelial ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more chemotherapies.