Posted by Michael Wonder on 30 May 2019
Bayer receives U.S. FDA breakthrough therapy designation for copanlisib for the treatment of marginal zone lymphoma
29 May 2019 - Breakthrough therapy designation for copanlisib primarily based on follow-up data from the pivotal Phase II study CHRONOS-1.
Bayer announced today that the U.S. FDA granted breakthrough therapy designation for copanlisib (Aliqopa) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies.
The breakthrough therapy designation was based on data from the MZL subgroup of the pivotal Phase II trial CHRONOS-1 that led to accelerated approval of copanlisib in the U.S. for the treatment of adult patients with relapsed follicular lymphoma (FL, the most common histological subtype of iNHL) who have received at least two prior systemic therapies.
