Κυριακή, 28 Φεβρουαρίου 2016

OBINTUZUMAB APPROVED FOR FOLLICULAR LYMPHOMA

The U.S. Food and Drug Administration (FDA) today approved obinutuzumab (Gazyva) for use in combination with bendamustine (Bendeka, Treanda) followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab (Rituxan)-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil (Leukeran) 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 in a randomized, open-label, multicenter trial in patients with follicular lymphoma who had no response to or have progressed during or within 6 months of a rituximab-containing regimen. This trial compared six cycles of obinutuzumab-plus-bendamustine combination therapy followed by continued obinutuzumab monotherapy for up to 2 years with six cycles of bendamustine therapy. 
Efficacy was assessed in 321 patients with follicular lymphoma randomized to either obinutuzumab plus bendamustine (n = 155) or bendamustine alone (n = 166). The median age was 63 years (range, 34–87). Patients had received a median of two prior therapies (range, 1–10). The independent review–assessed median progression-free survival was 13.8 months in the bendamustine arm, while the median progression-free survival was not reached in the obinutuzumab-plus-bendamustine arm (hazard ratio = 0.48, 95% confidence interval = 0.34–0.68; log-rank test P < .0001).
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 (≥ 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 (> 2%) were febrile neutropenia, neutropenia, infusion-related reactions, sepsis, pneumonia, and pyrexia.

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