Hemo-oncology newbie Bayer gears up for copanlisib launch

Bayer logo and dark clouds
Bayer's copanlisib snagged an FDA priority review in May.

MADRID, SpainAfter winning a May priority review from the FDA, Bayer should be hearing back on an approval for lymphoma prospect copanlisib sooner rather than later. And as the company ventures into the blood cancer space for the first time, it’s getting prepared.

The German drugmaker has its U.S. marketing teamcomprising both sales reps and a medical organizationin place, Robert LaCaze, Bayer EVP and head of its oncology strategic business unit, said in an interview at the European Society for Medical Oncology (ESMO) annual meeting. And while Bayer “has some internal people” working on the launch, it’s also staffed up and “brought in hematology experts.”

“We’ll utilize some very specific reps who will be focused on this,” he said, adding that the company’s plan is to launch from “an ownership standpoint.”

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RELATED: Bayer cancer drug boards path to speedy approval at FDA

It’s important that Bayer “actually bring in the right types of specialty and expertise” to call on blood cancer-treating doctors, LaCaze saidand not just because they’re a different group than the one Bayer has targeted with its launches for drugs including Stivarga and Xofigo.

“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.

If Bayer can snag an FDA approvalbased on phase 2 results that showed copanlisib could provoke a response in 58.7% of relapsed or refractory follicular lymphoma patients, completely ridding 14.4% of them of cancerit’ll go up against Gilead’s Zydelig, a med in copanlisib’s PI3K class that’s also approved for patients who have received two or more therapies.

RELATED: Zydelig 'dead in the water' after trial deaths force Gilead to stop frontline studies

And while Zydelig, taken in tablet form, is more convenient than the infused copanlisib, “there’s obviously some very positive benefits for this type of administration that counteract the fact that it is given by IV,” LaCaze said. Among them? Infusion “allows the physicians to help better monitor the patients,” he said.

There’s also plenty of precedent for turning to IV meds in the hemo-oncology space, he said, pointing to Roche giant Rituxan. “Most of these compounds are actually given on an IV basis anyway,” he noted.


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