Clovis Oncology (CLVS) Received FDA Approval for Rubraca as Monotherapy Treatment for Patients with BRCA1/2-Mutant, mCRPC

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Go back to Clovis Oncology (CLVS) Received FDA Approval for Rubraca as Monotherapy Treatment for Patients with BRCA1/2-Mutant, mCRPC

Rubraca® (Rucaparib) Approved in the U.S. as Monotherapy Treatment for Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Been Treated with Androgen Recept

May 15, 2020 2:30 PM EDT

Rubraca is the first PARP inhibitor approved in a prostate cancer setting

Accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the TRITON2 clinical triali

44% ORR (95% CI 31, 57) and median DOR not evaluable (95% CI 6.4, NE, range in months at data cutoff 1.7-24.0+) by blinded independent radiologic review (IRR)i

Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 lab abnormality was decrease in hemoglobini

BOULDER, Colo.--(BUSINESS WIRE)-- Clovis... More