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Spectrum Pharmaceuticals wins FDA approval for expanded label of cancer drug

Monday , September 07, 2009 09:47ET

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Sep 07, 2009 (Datamonitor via COMTEX) -- Spectrum Pharmaceuticals, a biopharmaceutical company, has announced that Zevalin, a CD20-directed radiotherapeutic antibody, received approval from the FDA for an expanded label for the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma, or NHL, who achieve a partial or complete response to first-line chemotherapy.

The new and expanded indication supplements the 2002 FDA approval of Zevalin as treatment for patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, said Spectrum.

The approval of the new indication was based on data from the Fit study. The multicenter, randomized, open-label Phase III study evaluated the safety and efficacy of Zevalin in 414 patients with CD20-positive follicular NHL who had achieved a partial response or a complete response after receiving a first-line chemotherapy regimen.

Patients were treated with one of the following first-line chemotherapy regimens: chlorambucil, fludarabine, fludarabine-containing regimen, CVP/COP, CHOP, CHOP-like, or rituximab-containing chemotherapy. At 3.5 years of follow-up, the Fit trial demonstrated that when used as part of first-line chemotherapy for patients with follicular NHL, Zevalin significantly improved the median progression-free survival time from 18 months (control arm) to 38 months (Zevalin arm) (p<0.0001), said Spectrum.

Rajesh Shrotriya, president and CEO of Spectrum, said: "We believe the approval of Zevalin as an effective treatment option following a first-line regimen represents a notable advance in the treatment of NHL, and significantly expands the addressable population for Zevalin. 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."

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