European Commission grants conditional approval for Roche's Polivy

Swiss pharma giant Roche (ROG: SIX) today announced that the European Commission has granted conditional marketing authorization for Polivy (polatuzumab vedotin), in combination with bendamustine plus MabThera (rituximab) (BR), for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a hematopoietic stem cell transplant.

“With this approval, people in the EU with relapsed or refractory diffuse large B-cell lymphoma will have the opportunity to benefit from this new Polivy combination,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “For patients battling this aggressive disease, the prognosis is poor and few treatments are available. We are proud to bring this first-in-class treatment option to those who need it most,” he added.

Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. It requires additional monitoring and post-marketing data before full approval is granted.

Strong clinical backing

The conditional approval 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 hematopoietic 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. Complete response rates were assessed by an independent review committee.