* Establishes November 20, 2011 as the Prescription Drug User Fee Act (PDUFA) Action Date
* Prior Approval Supplement, Submitted on January 20, 2011, Provides for the Removal of the Bioscan Requirement
* ZEVALIN® is Currently Approved By The FDA and Marketed by Spectrum Pharmaceuticals in the United States For:
o Treatment of Patients With Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
o Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin’s Lymphoma
IRVINE, CA, USA | March 22, 2011 | Spectrum Pharmaceuticals (NasdaqGS:SPPI – News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement containing data providing for the removal of the Indium-111 ZEVALIN® (ibritumomab tiuxetan) pre-treatment imaging evaluation, more commonly referred to as the “bioscan” requirement. A decision is expected by November 20, 2011.
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan), injection for intravenous use is indicated 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. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma.
ZEVALIN is a CD20-directed radiotherapeutic antibody. 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.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including Boxed WARNINGS, for ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
SOURCE: Spectrum Pharmaceuticals
Post Views: 38
* Establishes November 20, 2011 as the Prescription Drug User Fee Act (PDUFA) Action Date
* Prior Approval Supplement, Submitted on January 20, 2011, Provides for the Removal of the Bioscan Requirement
* ZEVALIN® is Currently Approved By The FDA and Marketed by Spectrum Pharmaceuticals in the United States For:
o Treatment of Patients With Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy
o Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin’s Lymphoma
IRVINE, CA, USA | March 22, 2011 | Spectrum Pharmaceuticals (NasdaqGS:SPPI – News), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement containing data providing for the removal of the Indium-111 ZEVALIN® (ibritumomab tiuxetan) pre-treatment imaging evaluation, more commonly referred to as the “bioscan” requirement. A decision is expected by November 20, 2011.
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan), injection for intravenous use is indicated 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. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma.
ZEVALIN is a CD20-directed radiotherapeutic antibody. 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.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including Boxed WARNINGS, for ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of novel drug candidates. The Company has assembled an integrated in-house scientific team, including clinical development, medical research, regulatory affairs, biostatistics and data management, formulation development, and has established a commercial infrastructure for the marketing of its drug products. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
SOURCE: Spectrum Pharmaceuticals
Post Views: 38
