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CHMP recommends EMA approval of polatuzumab vedotin for the treatment of adult patients with R/R DLBCL
On the 14th November 2019, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of polatuzumab vedotin, in combination with bendamustine and rituximab (BR), for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are unsuitable for a hematopoietic stem cell transplant.1 Polatuzumab vedotin is a first-in-class anti-CD79b antibody-drug conjugate, which kills malignant B cells by delivering anti-mitotic monomethyl auristatin E.2
The combination was approved earlier this year by the U.S. Food and Drug Administration (FDA) for the treatment of patients with DLBCL (read more here).
The CHMP’s positive opinion was based on data from the global phase Ib/II study GO29365 (NCT02257567) that evaluated the safety, tolerability, and activity of polatuzumab vedotin in combination with BR or obinutuzumab in R/R follicular lymphoma or DLBCL. The polatuzumab vedotin-BR combination achieved a complete response rate of 40% (n= 16/40) compared with 17.5% (n= 7/40) with BR alone, and a median survival of 12.4 months versus 4.7 months, respectively.3,4
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