CHMP Favors EU Approval of Lynparza for Some Advanced Breast Cancers

CHMP Favors EU Approval of Lynparza for Some Advanced Breast Cancers
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Lynparza (olaparib) tablets for the treatment of advanced breast cancer patients whose tumor is HER2-negative and positive for BRCA mutations. The recommendation is for patients already treated with chemotherapy — anthracycline and a taxane — unless they were not suitable for such treatments. Also, patients with hormone receptor (HR)-positive cancer should have received or been considered unsuitable for hormone therapy. The European Commission will now review CHMP’s opinion before making a decision. “Despite progress in treating patients with advanced breast cancer, there remains a significant unmet need for new treatment options,” Dave Fredrickson, executive vice president of oncology at AstraZeneca, said in a press release. “If approved, Lynparza will provide these patients with both a targeted and oral chemotherapy-free option.” Lynparza, developed by AstraZeneca and Merck (known as MSD outside the U.S. and Canada), is a PARP inhibitor that blocks the DNA repair process. The PARP enzyme is particularly relevant for DNA repair in people with BRCA mutations, and blocking it prevents the survival of tumors. Lynparza is currently available for the maintenance treatment of
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