AstraZeneca and Merck are racing against GlaxoSmithKline to snag an expanded nod for Lynparza in ovarian cancer patients who responded to their first round of chemo. And the partners just got a boost from the FDA.
The agency bestowed its priority review status on a combination of Lynparza and Roche’s Avastin, setting the duo up for an approval in first-line patients—with or without BRCA mutations—next quarter, the companies said Monday.
Regulators based their decision on data from the Phase 3 Paola-1 trial, presented at the European Society for Medical Oncology (ESMO) annual meeting in September, which showed the Lynparza-Avastin tandem could slash the risk of disease progression or death by 41% in patients with or without BRCA mutations.
Lynparza-Avastin patients across the board went a median 22.1 months without seeing their disease worsen, an advantage of more than six months over the Avastin-placebo arm.
What “every woman wants to know is, ‘how long will I benefit from this therapy?’ To be able to say at the median, it was nearly two years, that is a milestone we haven’t been able to achieve before,” Dave Fredrickson, executive vice president and global head of AstraZeneca’s oncology business unit, said at the time.
If Merck and AZ can score a nod for the Lynparza-Avastin pairing, it’ll be their second for Lynparza in the first-line ovarian cancer maintenance setting. Just over a year ago, the therapy grabbed a solo OK for women with BRCA mutations, cueing talk from analysts of a billion-dollar sales boost. Overall, the Avastin combo nod would be Lynparza’s fourth ovarian cancer approval.
But GlaxoSmithKline, which entered the PARP inhibitor field last January with its $5.1 billion Tesaro buyout, isn’t prepared to let AZ and Merck run the show. It unveiled its own positive data at ESMO from a first-line maintenance trial of Zejula, showing the drug could cut the risk of disease progression or death by 38%—without the addition of an additional drug and the toxicities that come along with it.