Gazyva Approved for Certain Patients with Follicular Lymphoma

The FDA has approved Roche's obinutuzumab, plus bendamustine chemotherapy, followed by Gazyva alone, as a new treatment option for patients with follicular lymphoma who did not respond to a previous regimen containing rituximab.

The FDA has approved Roche’s obinutuzumab (Gazyva), plus bendamustine chemotherapy, followed by Gazyva alone, as a new treatment option for patients with follicular lymphoma who did not respond to a previous regimen containing rituximab (Rituxan).

Gazyva can also be used in patients whose follicular lymphoma returns after such treatment.

The FDA approval was based on results from a phase 3 study. Results indicated that Gazyva/bendamustine, followed by Gazyva alone, could reduce the risk of disease worsening or death by 52%, compared with bendamustine alone.

“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, in a press release. “Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”

The treatment’s safety was evaluated in 392 patients with indolent non-Hodgkin lymphoma. Around 80% of these patients had follicular lymphoma.

The most common adverse effects of the drug in this trial were low white blood cell counts, nausea, fatigue, cough, and constipation. Some individuals also had diarrhea, fever, decreased appetite, or vomiting.

Gazyva was already approved, in combination with chlorambucil, for patients with previously untreated chronic lymphocytic leukemia.