Earlier this month, FDA experts voted—barely—that the agency should approve AstraZeneca and Merck’s Lynparza in pancreatic cancer. But that small majority was enough to convince regulators to follow suit.
The FDA greenlighted the drug Friday as a maintenance treatment for patients with germline BRCA-mutated disease who've already received a round of platinum-based chemo. The approval followed a priority review designation, awarded over the summer, and an orphan drug designation.
With the approval, AZ and Merck add a third disease area to the drug’s resume, which already includes indications in ovarian and breast cancers. And, for the third time, Lynparza is the first of its class of PARP inhibitors—which includes entrants from GlaxoSmithKline and Clovis Oncology—to break into a cancer type.
Regulators based the go-ahead on data from the phase 3 Polo trial, presented at this year’s American Society of Clinical Oncology meeting, which demonstrated Lynparza could slash the risk of disease worsening or death by 47%.
The results are “very exciting” considering “we are now able to offer a chemo-free option in maintenance to patients who for over a decade haven’t had any meaningful improvement,” Dave Fredrickson, executive vice president and global head of AstraZeneca’s oncology business unit, said at the time.
But FDA staffers weren’t so sure. They brought Lynparza’s case before an expert advisory committee, citing concerns about the Polo study’s size and the limitations of imaging technology to accurately measure tumor size.
Ultimately, those experts voted 7-5 in favor of approval, though, with the lack of other treatment options giving the drug a boost. While pancreatic cancer is rare, it’s also particularly deadly, bearing the lowest survival rate of the most common cancers. It’s also the only major cancer with a single-digit five-year survival rate in nearly every country, according to AstraZeneca.
While the vote was a narrow one, the corresponding approval didn’t surprise SVB Leerink analyst Andrew Berens and his colleagues, who, following the committee meeting, called an FDA nod “more likely than not.” And while they model a small sales boost from the latest OK—just $155 million in the U.S. and $50 million in the EU—they also “believe this favorable AdCom and potential approval could create a 'halo effect' for Lynparza, perhaps making the drug the PARP inhibitor of choice for the majority of medical oncologists," they wrote at the time.