Posted by Michael Wonder on 17 Nov 2019
CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma
15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells.
Roche today announced that the EU CHMP has adopted a positive opinion for Polivy (polatuzumab vedotin) in combination with bendamustine plus MabThera (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who are not candidates for a haematopoietic stem cell transplant. Based on this positive CHMP recommendation, a final decision regarding the conditional marketing authorisation of Polivy is expected from the European Commission in the near future.
The positive CHMP opinion is based on the results from the phase Ib/II GO29365 study, the first and only clinical trial to show higher response rates and improved overall survival compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a haematopoietic stem cell transplant.
