The class of PI3 kinase inhibitors will get a second shot at penetrating the market for follicular lymphoma, following accelerated approval of Bayer AG's Aliqopa (copanlisib) for use as a monotherapy after two prior systemic therapies, but the drug will need to prove it is safe and efficacious in combination regimens in Phase III to come into wider use.
The drug cleared the US FDA Sept. 14, and Bayer is planning to launch the drug immediately at the monthly wholesale acquisition cost of $12,600