Bayer Pulls Aliqopa Combo Filings In EU, US & Other Markets – But May Resubmit

The company plans to conduct additional analyses of data from ongoing trials that are testing its PI3K inhibitor in combination with rituximab for treating types of indolent B-cell non-Hodgkin’s lymphoma.

Doctors and medical researchers on conference meeting, discussing possible solutions for resolving a world health crisis.
More data will be analyzed from studies of Aliqopa used in combination with rituximab • Source: Alamy

Bayer is withdrawing its marketing applications in the EU, the US and several other markets for its PI3K inhibitor, Aliqopa (copanlisib), for use in combination with rituximab for treating subtypes of indolent B-cell non-Hodgkin’s lymphoma (iNHL).

The company told the Pink Sheet it was withdrawing the filings while it conducts additional analyses of data from ongoing studies to address specific questions it has received from the regulatory authorities in countries where it had filed for similar

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