AstraZeneca and Merck announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a marketing authorization of LYNPARZA (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high grade, epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. LYNPARZA is recommended for treatment in this setting regardless of patients’ BRCA mutation status.
“The data show that LYNPARZA provides long-term disease control, delaying the need for further chemotherapy for this broader group of women with platinum-sensitive relapsed ovarian cancer, irrespective of their BRCA status. It also offers a well-characterized safety and tolerability profile, which is critical to help enable patients to stay on treatment,” Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said.
The CHMP recommendation is based on two randomized trials, SOLO-2 and Study 19, which showed LYNPARZA (olaparib) reduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.