FDA Speeds Up the Approval Process for Bayer’s New Lymphoma Drug

17/05/2017 - 2 minutes

The FDA just granted Bayer priority review for copanlisib, a PI3K inhibitor which could be the next treatment for patients with non-Hodgkin’s lymphoma.

Bayer’s new PI3K drug was already in the spotlight in late March when the pharma giant came out with excellent data for its Phase II trial in patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (iNHL). As the company reported at the recent AACR meeting, the drug was able to hit a 59.2% overall response rate in treatment resistant patients, with a 12% complete response rate. Based on these results, the regulators have now decided to give Bayer a push and grant the company priority review.

The FDA’s decision refers to a New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. The Priority Designation means that the FDA will cut down its review time from 10 to 6 months and will provide Bayer access to the market based only on a Phase II trial, while its confirmatory Phase III trials run on the side.

Copanlisib inhibits the activity of phophatidylinositol-3 kinase (PI3K) α and δ isoforms.

The new PI3K inhibitor already picked up its first orphan drug designation from the FDA in 2015, which will give Bayer some additional advantages on the market. “Copanlisib may have a greater success and potential than we initially anticipated,” commented Bryan Garnier analysts in endpoints, consequently adjusting their peak sales estimate to $666M (€598M).

Current management of follicular lymphoma is mainly based on Roche’s blockbuster drug Rituximab, which targets the CD20 protein found on the surface of B cells. The new data indicates that with the approval of Bayer’s copanlisib, patients not responding to the standard treatment regimens could have new chances for a cure.

“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, in a press release.

Images via shutterstock.com /  Spectral-Design and CC 3.0 / Tbatan

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