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FDA approves Gazyva plus bendamustine to treat follicular lymphoma
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The FDA today approved obinutuzumab for use in combination with bendamustine chemotherapy followed by obinutuzumab monotherapy to treat patients with follicular lymphoma.
This approval of obinutuzumab (Gazyva, Genentech) is intended for patients who relapsed after, or who are refractory to, a rituximab (Rituxan; Genentech, Biogen Idec)-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,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said 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.”
Obinutuzumab previously received FDA approval for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.
The new approval is based in part on results from the phase 3 GADOLIN study, a randomized, open-label, multicenter trial composed of 321 patients with follicular lymphoma who had no response to or who progressed during or within 6 months of a rituximab-containing regimen.
Patients in the experimental arm received six cycles of obinutuzumab plus bendamustine combination therapy followed by continued obinutuzumab monotherapy for up to 2 years. Control patients received six cycles of bendamustine therapy alone.
Patients randomly assigned the combination demonstrated a 52% reduction in the risk for disease worsening or death (HR = 0.48, 95% CI, 0.34-0.68) compared with patients who received bendamustine alone.
Safety analyses included data from the 321 patients with follicular lymphoma, as well as from 46 patients with marginal zone lymphoma and 28 patients with small lymphocytic lymphoma. Results showed the most common adverse reactions associated with the obinutuzumab combination included infusion reactions, neutropenia, nausea, fatigue, cough, diarrhea, constipation, pyrexia, thrombocytopenia, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, anemia, general weakness and urinary tract infection.
Further, 38% of patients experienced serious adverse events, the most common of which included febrile neutropenia, neutropenia, infusion-related reactions, sepsis, pneumonia and pyrexia.
Obinutuzumab had previously received priority review for this application.