EMA’s CHMP Recommends Lynparza as Maintenance Therapy for Platinum-sensitive Ovarian Cancer

EMA’s CHMP Recommends Lynparza as Maintenance Therapy for Platinum-sensitive Ovarian Cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended that Lynparza (olaparib) be approved to prevent disease progression and relapse in ovarian cancer patients who responded to platinum-based chemotherapy, AstraZeneca and Merck announced. Lynparza inhibits the poly ADP-ribose polymerase (PARP) enzyme, which is required for the proper repair of DNA errors. While the medicine is particularly effective in cells with defective DNA damage repair, like those with a BRCA mutation, the recommendation is for patients with or without BRCA mutations. The U.S. Food and Drug Administration approved the medicine for a similar indication in August 2017. Both decisions are based on the results of two trials, the SOLO-2 Phase 3 trial (NCT01874353) and the Study 19 Phase 2 trial (NCT00753545). The SOLO-2 trial assessed Lynparza tablets (300 mg twice daily) as a maintenance therapy for ovarian cancer patients with BRCA mutations who had responded either partially or completely to at least two treatments of platinum-based chemotherapy. While women who received placebo had disease progression only 5.5 months after entering the trial, women receiving Lynparza remained alive and progression-free for 19.1 months. This represented a 70% reduced risk o
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