Last month, AstraZeneca and Merck’s Lynparza posted big-time ovarian cancer data, and regulators are taking note. The FDA has bestowed its priority review designation on the drug, setting it up for a billion-dollar opportunity—and a leg up on its PARP rivals.
Regulators put the cancer-fighter in line for a speedy review Monday as a maintenance treatment for BRCA-mutated ovarian cancer patients who have finished an initial round of chemo. With the boost, AZ and Merck should get a decision on the indication in the first quarter of next year.
The move follows results, unveiled in October, that showed Lynparza could reduce the risk of disease progression or death by a whopping 70%. Patients in the placebo arm went a median 13.8 months without their cancer worsening, while in the Lynparza group, the median still hadn’t been reached that point at 41 months and counting.
“We’ve doubled the number of women who are progression-free at three years versus what until today was standard of care,” Dave Fredrickson, EVP and global head of AZ’s oncology business unit, said in an interview at the European Society for Medical Oncology annual meeting, adding that “these data will be practice-changing.”
They’ll also be top line-changing for the partners, assuming they can come up with an FDA go-ahead. Evercore ISI analyst Steve Breazzano, for one, has estimated the value of the first-line ovarian cancer maintenance market at $1.4 billion, predicting that it will swell to $2.5 billion in the long run.
And as the first PARP contender to post positive data in this particular patient group, Lynparza could pick up the lion’s share. While it will eventually have to fight Clovis Oncology’s Rubraca and Tesaro’s Zejula for sales in the setting, for now, the AZ-Merck team is looking to make the most of its head start.
“We will be ready for our commercial launch the day we hear from our various health authorities,” Fredrickson said.
A green light for Lynparza in ovarian cancer maintenance would be its fourth; the drug, which has racked up $438 million for AZ through the first three quarters of the year and plays a key role in the British drugmaker’s return-to-growth strategy, also bears approvals in relapsed ovarian cancer and breast cancer.
Meanwhile, though, the pharma giants have run into reimbursement trouble with Lynparza across the pond. Last week, England's cost-effectiveness gatekeepers dismissed the high-flyer as too costly for patients in the second-line maintenance group.