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FDA Approves ZEVALIN® Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin’s Lymphoma

Tue, 09/08/2009 - 5:25am
Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a focus in oncology, has announced that ZEVALIN® (ibritumomab tiuxetan), 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 (NHL), who achieve a partial or complete response to first-line chemotherapy. This 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. “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. “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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