Roche's Gazyva gets FDA Priority Review for untreated lymphoma

Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said FDA accepted and granted Priority Review to an sBLA for Gazyva obinutuzumab (RG7159, GA101, RO5072759) to treat untreated follicular lymphoma when given in combination with chemotherapy followed by Gazyva monotherapy. Its PDUFA date is Dec. 23.

The glycoengineered humanized mAb against CD20 is approved in the U.S. in combination with Treanda bendamustine followed by Gazyva monotherapy to treat follicular lymphoma in patients who relapsed after or are refractory to a Rituxan rituximab-containing regimen. It is also approved in the U.S. and EU as first-line therapy for chronic lymphocytic leukemia (CLL) in combination with chlorambucil...