FDA

FDA shoves Bayer’s lymphoma drug copanlisib into the spotlight with its promise of a speedy review

Bayer is getting VIP treatment at the FDA for its mid-stage lymphoma drug copanlisib. Regulators agreed to give the drug a priority review — lopping 4 months off the standard 10 month cycle — and heightening its chances for a quick OK.

The PI3K drug — an IV therapy targeting PI3K-αlpha and delta — first gained some attention in late March when investigators reported that the treatment scored positive data for indolent non-Hodgkin lymphoma.

Werner Baumann, Bayer CEO

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.

Martin Dreyling, head of the lymphoma program at University Hospital — Grosshadern in Munich, Germany, turned up at AACR in April to highlight the drug’s efficacy and a “manageable” safety profile, according to OncLive, with their IV therapy comparing favorably to oral PI3K inhibitors.

And now the FDA will give Bayer a speedy review specifically for patients suffering from follicular lymphoma who have failed two previous therapies.

This is just the latest in a wave of priority reviews for new cancer drugs aimed at a very sick group of patients who are running out of options. It gives companies like Bayer, which has been building its cancer drug pipeline, a shortcut to the market with only a small Phase II while it works on other studies, including a confirmatory Phase III. And the FDA added orphan drug status, which comes with some advantages that will help as Bayer looks to expand its approval. That didn’t escape analysts’ attention.

“Copanlisib may have a greater success and potential than we initially anticipated,” Bryan Garnier analysts said, adding they would revise their current peak sales estimate of $666 million, according to a report in Reuters.

“With this milestone, we are one step closer to making copanlisib available in the U.S. to the community of doctors and patients facing a very difficult-to-treat disease,” said Carsten Brunn, head of Bayer Pharmaceuticals, Americas region.


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