Lynparza Recommended for Approval in Europe for BRCA-mutated Advanced OC

Lynparza Recommended for Approval in Europe for BRCA-mutated Advanced OC
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended that Lynparza (olaparib) be approved as a first-line maintenance therapy for women with BRCA-mutated advanced ovarian cancer, AstraZeneca and Merck announced. Specifically, the recommendation is for women who are responding, partially or completely, to their initial platinum-based chemotherapy. The U.S. Food and Drug Administration had already approved the therapy for the same indication in December 2018, establishing Lynparza as the first PARP inhibitor to be approved as a first-line maintenance therapy for BRCA-mutated advanced ovarian cancer. “There remains a significant unmet need in the treatment of advanced ovarian cancer as 70% of women globally relapse within the first three years after their initial treatment,” Dave Fredrickson, executive vice president and head of the oncology business unit at AstraZeneca, said in a press release. As cancer cells divide at a faster pace, they’re prone to accumulate more errors in their genome than healthy cells. Lynparza inhibits the poly ADP-ribose polymerase (PARP) enzyme and is designed to prevent cancer cells from repairing their DNA errors, which eventually causes them to die. The therapy is particularly effective in cancers with mutations in other DNA-repairing genes, such as BRCA1 and BRCA2. Both the CHMP’s recommendation and the FDA’s decision were based on clinical data from SOLO-1, an ongoing double-blinded, multicenter Phase 3 trial (NCT01844986) that is examining whether Lynparza is better than a placebo at extending the time patients live without their disease worsening. SOLO-1 enrolled 391 patients with high-grade serous or endometrioid ovarian cancer, prima
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