Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a focus in oncology, announced Zevalin (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, received approval from the US 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).
Zevalin (ibritumomab tiuxetan) is a CD20-directed radiotherapeutic antibody administered as part of the Zevalin therapeutic regimen. The Zevalin therapeutic regimen consists of three components: rituximab, Indium-111 (In-111) radiolabeled Zevalin for imaging, and Yttrium-90 (Y-90) radiolabeled Zevalin for therapy. The Zevalin therapeutic regimen is a form of cancer therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope.