FDA Approves Gazyva for Previously Treated Follicular Lymphoma

The FDA today approved a new therapeutic option for patients with previously treated lymphoma.

Obinutuzumab (Gazyva) plus bendamustine chemotherapy followed by Gazyva monotherapy was approved for patients with follicular lymphoma who did not respond to a regimen containing rituximab (Rituxan), or patients who experienced a recurrence of follicular lymphoma after 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 Genentech Chief Medical Officer and Head of Global Product Development, Sandra Horning, MD. “Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”

The approval followed the phase 3 GADOLIN study, which enrolled 392 patients suffering from follicular lymphoma who had disease progression during or within 6 months of previous Rituxan-based therapy.

An assessment by an independent review committee found patients administered Gazyva plus bendamustine followed by Gazyva monotherapy experienced a 52% decrease (HR=0.48, 95 percent CI 0.34-0.68, p<0.0001) in progression-free survival (PFS) compared with bendamustine alone.

The median PFS was not reached in the Gazyva treatment group compared with 13.8 months in the bendamustine monotherapy group.

The median PFS in the Gazyva cohort was 29.2 months compared with 13.7 months in the bendamustine group (HR=0.48, 95 percent CI 0.35-0.67, p<0.0001).

Furthermore, Gazyva reduced the risk of death by 38% compared with bendamustine in a post-hoc analysis with 24.1 months of median observation time. Median overall survival was not reached in either study group.

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

The most common side effects from Gazyva were low white blood cell counts, infusion reactions and low platelet counts.