AstraZeneca/Merck win EU approval for frontline maintenance treatment of ovarian cancer, months after FDA endorsement
AstraZeneca and Merck’s PARP inhibitor Lynparza has carved itself a niche in Europe.
Five months after getting a speedy approval from the US regulator for frontline maintenance treatment for BRCA-mutated ovarian cancer, the EU has followed suit, marking the first PARP inhibitor to win approval for the indication in the region.
The approval is based on results from a 391-patient study unveiled in October, which tested Lynparza against a placebo in patients given platinum-based chemotherapy. Data showed that 40.7 months of follow-up showed the median time of progression for patients treated with Lynparza had not yet been reached versus 13.8 months for those on placebo.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.