September 9, 2009 — The FDA has approved an expanded indication for ibritumomab tiuxetan intravenous infusion (Zevalin, Spectrum Pharmaceuticals) for the first-line treatment of follicular non-Hodgkin's lymphoma in patients who achieve a partial or complete response to chemotherapy.
The approval was based on 3.5-year data from the First-line Indolent Therapy multicenter, randomized, open-label, phase 3 study (n = 414), showing that progression-free survival was significantly prolonged among ibritumomab-treated patients compared with those who received no further treatment (38 months vs 18 months; P < .0001).
"We believe the approval of Zevalin as an effective treatment option following a first-line regimen represents a notable advance in the treatment of non-Hodgkin's Lymphoma, and significantly expands the addressable population for Zevalin," said Rajesh C. Shrotriya, MD, chairman, chief executive officer, and president of Spectrum Pharmaceuticals in a company news release, adding, "We are confident that the strategic and tactical initiatives we have implemented will overcome the clinical, logistical, and reimbursement challenges that have previously hindered physician and patient access to Zevalin."
Ibritumomab tiuxetan previously was approved for the treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
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