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EU approval for Roche's Polivy combo in relapsed/refractory B-cell lymphoma

Published on 21/01/20 at 12:53pm

The European Commission has awarded conditional marketing approval to Roche’s Polivy (polatuzumab vedotin), it has been revealed. The therapy is authorised for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), when combined with bendamustine plus MabThera (rituximab), for patients who are not candidates for a haematopoietic stem cell transplant.

Roche announced that the Phase 1b/2 results submitted in support of the application were the first and only to show superiority of a drug versus the commonly used regimen of bendamustine plus MabThera alone. Specifically, the Polivy regimen generated complete response rates of 40% compared to just 17.5 with bendamustine plus MabThera alone, while overall survival was more than doubled to a median of 12.4 months compared to 4.7 months.

Additionally, median duration of response was recorded as 10.3 months with the Polivy regimen compared to 4.1 months.

“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,” remarked 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.”

Matt Fellows

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