EMA approves Lynparza tablets for treatment of platinum-sensitive ovarian cancer

The European Medicines Agency (EMA) has approved AstraZeneca and Merck’s Lynparza (olaparib) tablets as maintenance therapy for the treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status.

Lynparza is a first-in-class poly ADP-ribose polymerase (PARP) inhibitor that has been designed to potentially exploit tumour DDR-pathway dependencies to preferentially kill cancer cells. It was initially licensed in Europe as a capsule formulation for women with BRCA-mutated platinum-sensitive relapsed ovarian cancer. The new tablet formulation reduces dosing from eight capsules twice daily to two tablets twice daily.

“With this new approval for Lynparza, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterised safety and tolerability profile,” stated Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca.

“This is an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease,” added Roy Baynes, senior vice president and head of Global Clinical Development, chief medical officer, MSD Research Laboratories. “Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women.”

The approval has been based on two randomised trials (SOLO-2 and Study 19) that demonstrated the efficacy of Lynparza in reducing the risk of disease progression or death in patients with platinum-sensitive relapsed ovarian cancer compare with placebo.