AstraZeneca's Lynparza Approved For Ovarian Cancer In EU

British pharma giant AstraZeneca reported that it has received the approval of the European Commission (EC) for its drug Lynparza (olaparib) as a first-in-class therapy for the maintenance treatment of adult patients with advanced BRCA-mutated ovarian cancer.

Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that kills cancer cells by leveraging the deficiencies in the tumor DNA repair pathway. Last month, AstraZeneca reported promising results for olaparib that showed the drug held potential for inducing tumor response rate in several late-stage cancers linked with BRCA1 and BRCA2 mutations.

The European Commission approved Lynparza to treat patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have demonstrated complete or partial response to platinum-based chemotherapy. Lynparza is the first PARP inhibitor to receive authorization for the treatment of platinum-sensitive relapsed BRCA-mutated ovarian cancer. The approval was earlier recommended by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

Briggs Morrison, EVP of global medicines development and CMO at AstraZeneca, said, “We are delighted to be able to bring this much needed treatment to patients with BRCA-mutated ovarian cancer whose options are currently very limited. Today’s approval marks a significant milestone in the development of the next generation of targeted medicines.”

Professor Steve Jackson, scientist at the University of Cambridge, and a key researcher in the development of olaparib, commented, “It is wonderful to learn that olaparib is set to become a licensed drug and will therefore soon become available to advanced ovarian cancer sufferers. I also look forward to learning the results of ongoing trials exploring olaparib's potential for the treatment of other cancers.”

Reuters reports that the British pharma firm considers Lynparza a potential $2-billion-a-year bestseller. The company is still waiting on the U.S. Food and Drug Administration (FDA) to issue a decision after a panel gave a negative opinion regarding Lynparza’s accelerated approval.