Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a marketing authorisation application to the EMA seeking approval of the novel combination of the cancer treatments copanlisib and rituximab.
The U.S. submission is for the treatment of patients with relapsed indolent B-cell non-Hodgkin’s lymphoma.
In the EU, Bayer has filed for the treatment of relapsed marginal zone lymphoma, a sub-type of indolent B-cell non-Hodgkin’s lymphoma, and the filing has been accepted.
