Spectrum's ZEVALIN expanded label receives FDA approval for treating non-Hodgkin’s Lymphoma

Spectrum Pharmaceuticals (NasdaqGM:SPPI), a commercial-stage biotechnology company with a focus in oncology, today announced ZEVALIN^® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the U.S. Food and Drug Administration (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.”

The approval of the new indication was based on data from the FIT Study (First-line Indolent Therapy). The multicenter, randomized, open-label Phase 3 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).

Updated results with an additional year of follow up were presented at the American Society of Hematology 2008 Annual Meeting. The safety profile of ZEVALIN was consistent with previous clinical studies, with hematologic toxicity as the most common adverse reaction in the FIT study.

“Our institution is one of the leading cancer research centers in the United States investigating the clinical utility of ZEVALIN in NHL therapy,” said Stephanie A. Gregory, MD, The Elodia Kehm Chair of Hematology, Professor of Medicine, and Director, Section of Hematology at Rush University Medical Center. “We believe that the approval of ZEVALIN as part of first-line chemotherapy represents an important advance in the treatment of patients with NHL.”

The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium currently lists chemotherapy followed by radioimmunotherapy, such as ZEVALIN, for patients with follicular NHL with a Category 1 recommendation. The Centers for Medicare & Medicaid Services (CMS) announced in June 2008 that it would recognize the NCCN Drugs & Biologics Compendium as a source of information to determine which drugs may be covered under Medicare Part B.