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.
Ovarian cancer is a leading cause of cancer deaths in women globally. Most women with newly diagnosed advanced ovarian cancer relapse within 3 years after standard treatment with surgery and platinum-based chemotherapy. “In SOLO-1, Lynparza demonstrated clinically-meaningful results with a 70% reduction in the risk of disease progression or death in the first-line maintenance treatment of patients with BRCAm advanced ovarian cancer,” said Roy Baynes, chief medical officer of MSD Research Laboratories, in a statement.
Under its alliance with Merck, AstraZeneca gets a tidy $30 million in connection with this approval, the British drugmaker said on Tuesday.
AstraZeneca $AZN is on a turnaround mission under CEO Pascal Soriot, as the British drugmaker prioritizes cancer with its oncology products such as Lynparza, Tagrisso and Imfinzi to help elevate its portfolio of treatments that have been bruised by generic treatments. Lynparza was the first PARP inhibitor to win US approval in 2014. Merck $MRK joined on as partner to expand its use in 2017. Last year sales of the drug more than doubled to $647 million.
Months after securing a lightning fast US approval for Lynparza in frontline ovarian cancer — widening its lead over the cluster of other PARPs including Tesaro’s (now GSK’s) Zejula and Clovis’ Rubraca — the drug in February showed promise in helping patients with BRCA-mutated metastatic pancreatic cancer live longer without their cancer progressing in a late-stage study.
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