Trial Confirms Rubraca’s Clinical Benefit Over Chemotherapy

Trial Confirms Rubraca’s Clinical Benefit Over Chemotherapy
Rubraca (rucaparib) is superior to chemotherapy at prolonging life without disease worsening in people with advanced ovarian cancer who received at least two prior lines of chemotherapy, according to top-line data from an ongoing Phase 3 trial. Data from the study, called ARIEL4 (NCT02855944), also showed that Rubraca's safety profile in these women, whose tumors contained mutations in the BRCA DNA repair gene, was consistent with that reported on the therapy’s approved label in Europe and the U.S. “We are pleased with these topline results from the ARIEL4 trial, which confirm the clinical benefit of Rubraca versus chemotherapy, including platinum-based chemotherapy, as a treatment for women with BRCA mutation-positive advanced ovarian cancer, including patients who are platinum-resistant,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, which developed the therapy, said in a press release. Rubraca is an oral, small molecule inhibitor of PARP enzymes. These enzymes are involved in DNA repair and in the control of programmed cell death. By blocking the activity of PARP enzymes, Rubraca is designed to prevent cancer cells from repairing their DNA, eventually killing them. Due to this mechanism of action, Rubraca is particularly effective at treating patients whose tumors contain mutations in DNA repair genes, such as BRCA1 and BRCA2. Rubraca was originally approved in the U.S. and Europe as a treatment for women with advanced ovarian cancer who had previously received at least two lines of chemotherapy and whose tumors contained BRCA mutations. Later, the medication’s approval was extended in both regions, to allow Rubraca to be given as a maintenance therapy to treat women with recurrent, platinum-sensitive ovarian cancer, regardless
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