Bayer to connect with China's drug regulator over pulling lymphoma drug from U.S.

Asian Tech Press (Nov 16) -- Bayer China said Thursday it will communicate closely with China's drug regulator over the withdrawal of its lymphoma drug from the U.S. market.

This followed reports that Bayer decided to withdraw copanlisib, an inhibitor of phosphatidylinositol-3-kinase (PI3K), from the U.S. market after a postmarketing trial failed to conclusively prove the clinical benefit of the drug.

Bayer said in a statement on Monday that "following discussions with the U.S. Food and Drug Administration (FDA), it will work with the FDA on a voluntary withdrawal of the Aliqopa® (copanlisib) U.S. New Drug Application for adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies."

In May this year, Bayer also received approval to market the drug in China, treating adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

As to whether the withdrawal in the U.S. will affect the Chinese market, Bayer China replied on Thursday that at present, copanlisib has not officially gone on sale in mainland China.

Bayer China said the company will also communicate closely with the National Medical Products Administration (NMPA) on its decision to voluntarily withdraw copanlisib.

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