FDA, Immuno-oncology

FDA hands AstraZeneca and Merck a snap OK to market Lynparza in frontline ovarian cancer, marking a new standard in treatment

AstraZeneca just showed how fast an established cancer drug can achieve a crucial line extension.

Just two months after the pharma giant and its partners at Merck turned up at ESMO to tout some truly impressive detailed results for Lynparza as a frontline therapy for BRCA-mutated ovarian cancer, the agency has come through with a snap OK.

The key data point: A hazard ratio of 0.30, with a profound 70% reduction in risk of death. These days, the FDA is not reluctant to slap an OK on a cancer drug, and AstraZeneca’s R&D team has spent years working on an expanded market for the drug after winning the pioneering approval for a PARP inhibitor.

GSK’s recent arrival on the scene with a buyout for a now shrunken PARP rival has underscored the lead that AstraZeneca and Merck have built up here. And shares of Clovis declined 6% after the news, which further overshadowed its PARP Rubraca.

In the SOLO-1 study 60% of the women receiving the drug were progression-free at 3 years, compared to less than half that in the placebo group.

Kathleen Moore

AstraZeneca’s success with Lynparza and Tagrisso, with early inroads involving Imfinzi, have helped pave a long-awaited turnaround for the company, which has suffered through a dramatic onslaught of generic competition as their franchise drugs lost patent protection. And the FDA, which has signaled its readiness to speed up the game of R&D, has wasted no time in helping them swiftly advance.

“SOLO-1 is truly a landmark trial in gynecologic cancer.” said Kathleen Moore, the co-principal investigator.”This approval will likely change the way we treat women with BRCA-mutated advanced ovarian cancer. The ability to offer this important first-line maintenance treatment option to eligible patients may slow down or even stop the natural course of disease progression.”


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Biotech Investment Analyst
SV Health Investors Boston, MA
Director, Program Management
Contrafect Corporation New York, NY
Director, Translational Sciences
Cadent Therapeutics Cambridge, MA

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