May 15, 2020
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FDA approves Rubraca for prostate cancer subset

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The FDA granted accelerated approval to rucaparib for treatment of men with BRCA-mutated metastatic castration resistant prostate cancer.

The approval applies to use of rucaparib (Rubraca, Clovis Oncology) by men who have undergone prior treatment with an androgen receptor-directed therapy and a taxane-based chemotherapy.

The FDA based approval on results of the TRITON2 trial, an ongoing, multicenter study that included 115 men with BRCA-mutated metastatic castration-resistant prostate cancer who had been treated with androgen receptor-directed therapy and taxane-based chemotherapy.

Patients received rucaparib dosed at 600 mg orally twice daily and concomitant GnRH analog or had prior bilateral orchiectomy.

Investigators assessed objective response rate and duration of response among 62 men with measurable disease.

Researchers reported a confirmed ORR of 44% (95% CI, 31-57). Median duration of response had not been reached (95% CI, 6.4-not estimable). Some men remained in response for more than 24 months.

Fifteen (56%) of the 27 men with confirmed objective responses remained in response for more than 6 months.

The most common adverse reactions among all men in the study included fatigue, nausea, anemia, increased alanine aminotransferase and aspartate aminotransferase levels, decreased appetite, rash, constipation, thrombocytopenia, vomiting and diarrhea.