Policy & Regulation
Genentech receives USFDA approval for Polivy combination
12 June 2019 -

Genentech, a subsidiary of Roche, has received approval from the US Food and Drug Administration (USFDA) for Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) for the treatment of diffuse large B-cell lymphoma, it was reported yesterday.

The accelerated approval covers treatment of adult patients with diffuse large B-cell lymphoma whose condition is either relapsed or refractory (R/R) and had been subjected to more than two prior therapies.

Approval was granted based on complete response rates shown by patients treated with the drug combination in a randomised, controlled phase Ib/II clinical trial, and because the drug meets an unmet medical need for a serious condition. Continued approval for the indication is likely to be based on verification and clinical benefit shown in a confirmatory trial.