FDA Accepts For Review Spectrum's Response On ZEVALIN As A Class 1 Submission, And Establishes September 7, 2009 As Decision Date

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 22 Jul 2009 - 1:00 PDT

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Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a focus on oncology, announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the resubmission to the Company's supplement to the biologics license application for ZEVALIN (ibritumomab tiuxetan) in the first line consolidation setting on July 8, 2009. The FDA considers the review as a Class 1 submission to their complete response letter of July 2, 2009. Therefore, the user fee goal date is September 7, 2009.

ZEVALIN is currently FDA approved and marketed by Spectrum Pharmaceuticals for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's Lymphoma, including patients who have rituximab-refractory follicular non-Hodgkin's Lymphoma.

About ZEVALIN®

ZEVALIN® (ibritumomab tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan®) infusions. Yttrium-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the ZEVALIN therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to ZEVALIN therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). ZEVALIN should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

For more information on ZEVALIN, patients and healthcare professionals can visit http://www.ZEVALIN.com.

Source
Spectrum Pharmaceuticals

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