A little more than a year ago, Gilead ran into some serious problems when its PI3K cancer pill Zydelig was linked with a rash of deaths in frontline studies, crippling what was once considered a potential blockbuster sales effort. Now Bayer is coming along with an infused rival that will try and start to follow up on the success enjoyed by Johnson & Johnson $JNJ and AbbVie’s $ABBV Imbruvica, a potential mega-blockbuster player which has been scoring some big gains in leukemia and lymphoma.
The FDA has approved Bayer’s copanlisib, with will now be marketed as Aliqopa for relapsed follicular lymphoma. Regulators were quick to follow up after providing Bayer’s cancer prospect with a priority review, lopping 4 months off the regulatory process.
Bayer has some limited ambitions here, saying earlier that it expects to rack up about $600 million a year, in line with analysts estimates for its peak sales potential.
The primary endpoint in Phase II, which is being used for the accelerated approval, was overall response among treatment resistant patients. And in all groups the ORR of 59.2%, with a 12% complete response rate and a median duration of response of more than 98 weeks, or 687 days. But pulling out the 104 follicular lymphoma patients in CHRONOS-1, copanlisib scored an ORR of 58.7%, including a complete response of 14.4% and a median DOR of more than 52 weeks, or 370 days.
“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence. “Options are limited for these patients and today’s approval provides an additional choice for treatment, filling an unmet need for them.”
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