Aliqopa (copanlisib): Withdrawal of the marketing authorisation application

Bayer AG withdrew its application for a marketing authorisation of Aliqopa for the treatment of adult patients with previously treated marginal zone lymphoma (MZL), a cancer of a type of white blood cells called B lymphocytes or B cells.

The company withdrew the application on 20 December 2021.

In its letter notifying the Agency of the withdrawal of the application, the company stated that the decision was based on the need to await further analyses/data to further characterize the benefits and the risks, in particular for the combination treatment.