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FDA Grants Rucaparib Breakthrough Designation for mCRPC

Ariela Katz
Published: Tuesday, Oct 02, 2018

The FDA has granted the PARP inhibitor rucaparib (Rubraca) a breakthrough therapy designation for single-agent use in adult patients with BRCA1/2-positive metastatic castration-resistant prostate cancer (mCRPC) following at least 1 androgen receptor–directed therapy and taxane-based chemotherapy.1

The primary endpoints are objective response rate, and prostate-specific antigen (PSA) response. Secondary outcome measures include duration of response, radiologic progression-free survival, overall survival, clinical benefit rate, time to PSA progression, and safety/tolerability. The estimated primary completion date is October 2019.

“We are pleased the FDA has granted breakthrough therapy designation to Rubraca in mCRPC,” Howard R. Soule, PhD, executive vice president and chief scientific officer of the Prostate Cancer Foundation, said in a statement. “There is tremendous need for new therapeutic options in advanced prostate cancer. In particular, we are enthusiastic about the potential for targeted therapies that may provide more meaningful benefit to patients with specific genetic mutations.”
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