Spectrum Pharmaceuticals Announces ZEVALIN Data Presentations at the 51st Annual Meeting of the American Society of Hematology in New Orleans

  • A Total Of 14 Abstracts On ZEVALIN®  
  • Two Oral Presentations  
  • ZEVALIN is Currently Approved For:
    • Treatment of Patients With Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL), Who Achieve a Partial or Complete Response to First-Line Chemotherapy  
    • Treatment of Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma  
     

IRVINE, Calif.--(BUSINESS WIRE)--Dec 1, 2009 - Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a primary focus in oncology, today announced that clinical data on ZEVALIN will be presented at the 51st Annual Meeting of the American Society of Hematology (ASH), being held December 5-8, 2009 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

The following are the abstracts being presented at the conference:

Date     Location     Abstract     Title
Saturday, December 5, 5:30pm-7:30pm     Poster Board I-724     1702     Overall Survival (OS) Benefit of Rituximab Based Immunochemotherapy Followed by Post-Induction Treatment in Mantle Cell Lymphoma (MCL) a Retrospective Analysis of 279 Patients Treated by Polish Lymphoma Research Group (PLRG) Centers
Saturday, December 5, 5:30pm-7:30pm     Poster Board I-725     1703     Feasibility and Toxicity After Induction Treatment with Rituximab-HCVAD and Methotrexate/Citarabine, Followed by Consolidation with y-90 Ibritumomab Tiuxetan (Phase 2 GELTAMO-LCM 04-02 study)
Saturday, December 5, 5:30pm-7:30pm     Poster Board I-226     1204     Outcomes of Early Relapse Following Non-Myeloablative Allogenic Transplant for Lymphoma
Sunday, December 6, 6pm-8pm     Poster Board II-300     2323     Yttrium 90 Plus High Dose BEAM Conditioning with Autologous Stem Cell Transplantation (ASCT); Effects of Prior Rituximab and Outcome of Poor Risk Non-Hodgkin Lymphoma (NHL)
Sunday, December 6, 6pm-8pm     Poster Board II-696     2720     A Phase II Trial of Rituximab-CHOP Chemotherapy Followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (90Y-IT) for Previously Untreated Elderly Diffuse Large B-Cell Lymphoma (BLBCL) Patients
Monday, December 7, 6pm-8pm     Poster Board III-679     3743     A Phase 2 Trial of R-FM (Rituximab, Fludarabine and Mitoxantrone) Chemotherapy Followed by Yttrium 90 (90Y) Ibritumomab Tiuxetan (90Y-IT) for Untreated Follicular Lymphoma (FL) Patients
Monday, December 7, 6pm-8pm     Poster Board III-687     3751     Phase 2 Trial of 90Y-Ibritumomab Tiuxetan Treatment as Consolidation After 6th R-CHOP Chemotherapy in Patients with Limited-Stage, Bulky Diffuse Large B-Cell Lymphoma
Monday, December 7, 6pm-8pm     Poster Board III-682     3746     Consolidation with Radioimmunotherapy May Prolong Survival in First Remission of Mantle Cell Lymphoma Patients Ineligible for Stem Cell Transplantation, an Analysis of the International RIT-Network
Monday, December 7, 6pm-8pm     Poster Board III-360     3423     Y90 Plus High Dose BEAM with Autologous Stem Cell Transplantation for Chemorefractory Non-Hodgkin Lymphoma
Monday, December 7, 6pm-8pm     Poster Board III-475     3538     No Harmful Impact of 90Yttrium-Ibritumomab Tiuxetan Combined with BEAM on Bone Marrow Microenvironment
Monday, December 7, 6pm-8pm     Poster Board III-294     3357     90y-Ibritumomab Tiuxetan (ZEVALIN®) May Enhance Anti-Lymphoma Effect of Reduced-Intensity Fludarabine and Melphalan Regimen in Patients with Relapsed, Refractory B-Cell Non-Hodgkin Lymphoma (NHL) Undergoing Allogenic Hematopoietic Cell Transplant (Allo-HCT)
Monday, December 7, 6pm-8pm     Poster Board III-147     3210     90y-Ibritumomab Tiuxetan on Purine Analogues Severely Affect Peripheral Blood Stem Cell Mobilization: An Analysis on 248 Patients
Tuesday, December 8, 7:45am     Oral Session: Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Treatment of B-cell Lymphomas with Anti-CD20 Antibodies     932     90y-Ibritumomab Tiuxetan (ZEVALIN®)-Beam/C with Autologous Stem Cell Support as Frontline Therapy for Advanced Mantle Cell Lymphoma - Preliminary Results from the Third Nordic MCL Phase II Study (MCL3)
Tuesday, December 8, 8:15am     Oral Session: Clinical Care - Transplantation Regimen Toxicities and Engraftment: Ways to Improve Outcome of all SCT for Malignant and Genetic Diseases     868     Stem Cell Transplantation with 90yttrium Ibritumomab Tiuxetan (90YIT) in Non-Hodgkin's Lymphoma (NHL): Observations from PET Pre-Treatment Imaging and Responses in Allografted Follicular Histologies
                   

For more information about the ASH annual meeting and for a complete list of abstracts, please refer to the conference Web site at www.hematology.org.

 

About ZEVALIN® and the ZEVALIN Therapeutic Regimen

ZEVALIN (ibritumomab tiuxetan) 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 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.

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.

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a primary focus in oncology. The Company's strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company's website at www.sppirx.com.

Forward Looking Statements – This press release may also contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to Spectrum's business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for Spectrum's approved drugs, continuing to build Spectrum's team, leveraging the expertise of partners around the world to assist Spectrum in the execution of its strategy, the safety and efficacy of ZEVALIN and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum's existing and new drug candidates may not prove safe or effective, the possibility that Spectrum's existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that Spectrum's existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that Spectrum's efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum's lack of revenues, limited marketing experience, dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum's reports filed with the Securities and Exchange Commission. Spectrum does not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

 

Contact: Spectrum Pharmaceuticals, Inc. Paul Arndt Senior Manager, Investor Relations 949-788-6700 x216

 

 

Posted: December 2009

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