Bayer only won its FDA priority review for lymphoma prospect copanlisib this May, but that was long enough for the agency to make up its mind on the med.
Thursday, regulators said they had green-lighted the product, to be known commercially as Aliqopa, in relapsed follicular lymphoma patients who have received at least two prior treatments. The approval comes based on phase 2 data that showed copanlisib could provoke a response in 58.7% of relapsed or refractory follicular lymphoma patients, completely ridding 14.4% of them of cancer.
The drug, a member of the PI3K class, will go head-to-head with Gilead’s Zydelig, a treatment whose life cycle hasn’t exactly gone according to plan. Last March, serious side effects and multiple deaths among trial participants forced the Big Biotech to nix its studies testing the med in the first-line setting.
It’s still around for relapsed patients, though, and Bayer is hoping it can beat out the $168 million Zydelig generated last year. While Aliqopa is an injectable—potentially less convenient than Zydelig, a tablet—the German drugmaker doesn’t think its new med’s format will be an issue.
“There’s obviously some very positive benefits for this type of administration that counteract the fact that it is given by IV,” Robert LaCaze, Bayer EVP and head of Bayer’s oncology strategic business unit, said in an interview earlier this week, noting that it “allows the physicians to help better monitor the patients.”
The launch, meanwhile, will mark Bayer’s first foray into blood cancer, and it’s prepared accordingly. The company has hired hematology experts to staff its sales force and medical organization, Lacaze said, adding that Bayer wants to roll out Aliqopa “from an ownership standpoint.”
“The types of endpoints that you treat … oftentimes in the hematology space, they’re different than what you see in the solid-tumor space,” he said, and that makes “matching up the right skill set with our field force to the physician and the types of patients that they’re seeing” critical.
Aliqopa will join growth products Stivarga and Xofigo, as well as older blockbuster Nexavar, in Bayer’s cancer portfolio. Stivarga also recently scored an approval, in April securing the FDA’s favor as a therapy for second-line liver cancer.