The U.S. Food and Drug Administration has given Bayer a priority review for its New Drug Application for copanlisib, a drug to be used for relapses of refractory follicular lymphoma in individuals who have had a minimum of two therapies.
The application will optimistically be completed within six months and the drug's approval will make it available for individuals who need it.
"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," Carsten Brunn, head of Bayer Pharmaceuticals,said.
The data that was submitted with the application was from a Phase II open-label, single-arm CHRONOS-1 study, based on individuals with relapsed or refractory indolent non-Hodgkin's lymphoma. The study considered 142 patients.
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