(RTTNews) - Roche (RHHBY) said that the EU Committee for Medicinal Products for Human Use or 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 or DLBCL, who are not candidates for a haematopoietic stem cell transplant.
Based on the 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 (OS) compared to BR, a commonly used regimen, in people with R/R DLBCL who are not candidates for a haematopoietic stem cell transplant.
Results of the study showed that 40% of people treated with Polivy plus BR achieved a complete response (n=16/40), meaning no cancer could be detected at the time of assessment, compared to 17.5% (n=7/40) with BR alone.
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