Trial results showed overall survival was shorter compared with chemotherapy. The move doesn’t affect other indications.
Clovis Oncology has withdrawn the indication of Rubraca (rucaparib) in the United States as a treatment for patients with BRCA-mutated ovarian cancer after two or more chemotherapies. This withdrawal became effective June 10, 2022, and does not affect other indications for Rubraca.
A recent trial found that in patients with BRCA-mutated epithelial ovarian, Fallopian tubes or primary peritoneal cancer and treated with Rubraca, overall survival was shorter than with those treated with chemotherapy. The results from this trial, ARIEL4, were reported at the 2022 meeting of European Society of Medical Oncology.
Survival in patients treated with Rubraca was 19.6 months compared with 27.1 months for those treated with chemotherapy, with a hazard ratio of 1.550. A hazard ratio above 1 indicates there is harm to the patient.
Clovis has voluntarily requested withdrawal of the treatment indication in Europe.
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3. In the United States, the FDA approved Rubraca in 2018 as a third-line maintenance treatment of adult patients with recurrent epithelial, ovarian, fallopian tube, or primary peritoneal cancer in patients with least two prior treatments of platinum-based chemotherapy. It is also approved for patients with BRCA mutated metastatic castration-resistant prostate cancer.
Clovis recently reported data from the phase 3 ATHENA-MONO trial of Rubraca as a first-line maintenance therapy in ovarian cancer. Rubraca as first-line maintenance treatment improved progression-free survival compared with placebo in women with advanced ovarian cancer irrespective of biomarker status. Clovis intends to submit a supplemental application to both the FDA and EMA for this indication. The company indicated that overall survival data from ATHENA-MONO won’t be available for about 2 years.
About 39% to 44% of women who inherit a BRCA1 variant and 11% to 17% of women who inherit a BRCA2 variant will develop ovarian cancer, according to the National Cancer Institute.