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  1. Resources for Information | Approved Drugs

On February 26, 2016, the U. S. Food and Drug Administration approved obinutuzumab (Gazyva Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.

This new approval was based on demonstration of an improvement in progression-free survival (PFS) in a randomized, open-label, multicenter trial in patients with FL who had no response to or have progressed during or within 6 months of a rituximab-containing regimen. This trial compared 6 cycles of obinutuzumab plus bendamustine combination therapy followed by continued obinutuzumab monotherapy for up to 2 years with 6 cycles of bendamustine therapy. 

Efficacy was assessed in 321 patients with follicular lymphoma randomized to either obinutuzumab plus bendamustine (n=155) or bendamustine (n=166). The median age was 63 years (range 34-87). Patients had received a median of 2 prior therapies (range 1-10). The independent review assessed median PFS was 13.8 months in the bendamustine arm while the median PFS was not reached in the obinutuzumab plus bendamustine arm [HR 0.48 (95% CI: 0.34-0.68), log-rank test p-value

This trial also enrolled 46 patients with marginal zone lymphoma and 28 with small lymphocytic lymphoma who were also included in the safety analysis. The most common adverse reactions (greater than or equal to 10%) in the safety population treated with obinutuzumab plus bendamustine followed by obinutuzumab monotherapy were infusion reactions, neutropenia, nausea, fatigue, cough, diarrhea, constipation, pyrexia, thrombocytopenia, vomiting, upper respiratory tract infection, decreased appetite, arthralgia, sinusitis, anemia, asthenia and urinary tract infection. Serious adverse reactions were reported in 38% of patients treated with obinutuzumab plus bendamustine followed by obinutuzumab monotherapy. The most common serious adverse reactions (greater than 2%) were febrile neutropenia, neutropenia, infusion related reactions, sepsis, pneumonia and pyrexia.

The recommended dose and schedule for the regimen follows:

Obinutuzumab: 1000 mg by intravenous infusion on days 1, 8 and 15 of cycle 1; on day 1 of cycles 2-6 (28-day cycles); and then every 2 months for 2 years. 

Bendamustine: 90 mg/m2 by intravenous infusion on days 1 and 2 of cycles 1-6.

This application was granted Priority Review. A description of these expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.

Full prescribing information is available at: 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

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