FDA Approves Obinutuzumab for Select Patients With Previously Treated Follicular Lymphoma

The U.S. Food and Drug Administration approved obinutuzumab (Gazyva) in combination with bendamustine chemotherapy followed by obinutuzumab alone for the treatment of certain patients with follicular lymphoma. This regimen is indicated for patients who relapsed after or are refractory to a rituximab-containing regimen.

“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, MD, chief medical officer and head of Global Product Development. “Gazyva plus bendamustine provides a new treatment option that can be used after relapse to significantly reduce the risk of progression or death.”

Approval is based on findings from the phase 3 GADOLIN trial, which demonstrated a significant reduction in progression-free survival with obinutuzumab plus bendamustine followed by obinutuzumab alone compared with bendamustine alone (HR, 0.48; 95% CI, 0.34 – 0.68; P < .0001).

In terms of safety, the most common grade 3 to 4 toxicities associated with this treatment regimen were neutropenia, infusion reactions, and thrombocytopenia.

The most frequently reported treatment-emergent adverse events were infusion reactions, neutropenia, nausea, fatigue, cough, diarrhea, constipation, fever, thrombocytopenia, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, anemia, malaise, and general weakness, and urinary tract infection.

For the open-label study, researchers randomly assigned patients with CD20+ rituximab-refractory indolent non-Hodgkin lymphoma, of whom 81% had follicular lymphoma, to receive bendamustine 120 mg/m² IV alone on days 1 and 2 for 6 cycles, or bendamustine 90 mg/m² IV on days 1 and 2 for 6 cycles plus obinutuzumab 1000 mg IV on days 1, 8, and 15 of cycle 1 and day 1 of cycles 2 through 6.

This is the second indication for obinutuzumab, which is approved in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

Reference

1. FDA approves Genentech’s Gazyva® (obinutuzumab) for certain people with previously treated follicular lymphoma [news release]. South San Francisco, CA: Genentech; February 26, 2016. http://www.gene.com/media/press-releases/14618/2016-02-26/fda-approves-genentechs-gazyva-obinutuzu. Accessed February 26, 2016.