FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA-Mutated Metastatic Castrate-Resistant Prostate Cancer

Author:

Anscher Mitchell S.1,Chang Elaine1,Gao Xin1,Gong Yutao1,Weinstock Chana1,Bloomquist Erik1,Adeniyi Oluseyi1,Charlab Rosane1,Zimmerman Sarah1,Serlemitsos-Day Maritsa1,Ning Yang Min1,Mayrosh Ruth1,Fuller Barbara1,Trentacosti Ann Marie1,Gallagher Pamela2,Bijwaard Karen2,Philip Reena2,Ghosh Soma2,Fahnbulleh Frances1,Diggs Felicia1,Arora Shaily1,Goldberg Kirsten B.3,Tang Shenghui1,Amiri-Kordestani Laleh1,Pazdur Richard13,Ibrahim Amna1,Beaver Julia A.13

Affiliation:

1. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

2. Center for Devices and Radiologic Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

3. Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland, USA

Abstract

Abstract The U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib in May 2020 for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castrate-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane. This approval was based on data from the ongoing multicenter, open-label single-arm trial TRITON2. The primary endpoint, confirmed objective response rate, in the 62 patients who met the above criteria, was 44% (95% confidence interval [CI]: 31%–57%). The median duration of response was not estimable (95% CI: 6.4 to not estimable). Fifty-six percent of patients had a response duration of >6 months and 15% >12 months. The safety profile of rucaparib was generally consistent with that of the class of poly-(ADP-ribose) polymerase enzyme inhibitors and other trials of rucaparib in the treatment of ovarian cancer. Deaths due to adverse events (AEs) occurred in 1.7% of patients, and 8% discontinued rucaparib because of an AE. Grade 3–4 AEs occurred in 59% of patients. No patients with prostate cancer developed myelodysplastic syndrome or acute myeloid leukemia. The trial TRITON3 in patients with mCRPC is ongoing and is planned to verify the clinical benefit of rucaparib in mCRPC. This article summarizes the FDA thought process and data supporting this accelerated approval. Implications for Practice The accelerated approval of rucaparib for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castrate-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane represents the first approved therapy for this selected patient population. This approval was based on a single-arm trial demonstrating a confirmed objective response rate greater than that of available therapy with a favorable duration of response and an acceptable toxicity profile. The ongoing trial TRITON3 is verifying the clinical benefit of this drug.

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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