FDA approves expanded uses of Genentech's Gazyva and Novartis' Afinitor

US biotech firm Genentech, a subsidiary of Swiss pharma giant Roche (ROG: SIX), has received approval from the US Food and Drug Administration for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.

“People with follicular lymphoma whose disease returns or worsens despite treatment with a Rituxan-containing regimen need more options because the disease becomes more difficult to treat each time it comes back,” said Sandra Horning, chief medical officer and head of global product development, adding: “Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”

With this approval, Gazyva is approved in the USA to treat two common types of blood cancer. Gazyva is also approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL) based on data from the pivotal CLL11 study, which compared Gazyva plus chlorambucil head-to-head with Rituxan plus chlorambucil.