Spectrum Pharmaceuticals Announces 19 ZEVALIN Presentations at the 53rd Annual Meeting of the American Society of Hematology (ASH) in San Diego, California, December 10-13, 2011

  • Five Abstracts Selected By the Lymphoma Review Committee for Oral Presentation
  • ZEVALIN Is Currently Approved By The FDA And Marketed By Spectrum Pharmaceuticals In The United States For:
    • Treatment Of Patients With Previously Untreated Follicular Non-Hodgkin 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 Lymphoma

HENDERSON, Nev.--(BUSINESS WIRE)--Dec 9, 2011 - Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced a total of 19 ZEVALIN related data presentations (5 oral, 14 posters) at the 53rd Annual Meeting of the American Society of Hematology (ASH), being held in San Diego, California, from December 10-13, 2011.

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.

The following are the key ZEVALIN-related abstracts being presented at the conference:

                 
ORAL PRESENTATIONS

 

               
Date

 

  Time

 

  Abstract#

 

  Type

 

  Title

 

  First Author

 

  Location

 

Sunday, December 11, 2011                
                 
    5:00 PM   99   Oral   Phase II Study with R-FND Followed by 90-Y Ibritumomab Tiuxetan Radioimmunotherapy and Rituximab Maintenance for Untreated High-Risk Follicular Lymphoma   Fowler   Room 6B
                         
    5:15 PM   100   Oral   Safety and Efficacy of 90Y Ibritumomab Tiuxetan (Zevalin®) for Untreated Follicular Non-Hodgkin's Lymphoma (FL) Patients, An Italian Cooperative Study

 

  Pica   Room 6B
                         
    5:30 PM   101   Oral   A Systematic Review and Meta-Analysis of Radioimmunotherapy Consolidation for Untreated Patients with Follicular Lymphoma (FL)   Rose   Room 6B
                         
    5:45 PM   102   Oral   Fractionated 90y Ibritumomab Tiuxetan (ZevalinTM) Radioimmunotherapy As An Initial Therapy of Follicular Lymphoma – First Results From a Phase II Study in Patients Requiring Treatment According to GELF/BNLI Criteria

 

  Illidge   Room 6B
                         
Monday, December 12, 2011                
                 
    3:00 PM   662   Oral   Nonmyeloablative Allogeneic Stem Cell Transplantation with/ or without 90yttrium Ibritumomab Tiuxetan (90YIT) Is Curative for Relapsed Follicular Lymphoma: Median 9 Year Follow-up Results   Khouri   Douglas Pavilion C
                         
POSTER PRESENTATIONS

 

               
Date

 

  Time

 

  Abstract#

 

  Type

 

  Title

 

  First Author

 

  Location

 

Saturday, December 10, 2011            
             
    5:30 PM-7:30 PM

 

  1572   Poster   Risk of Transformation of Follicular Lymphoma: A Prospective Observational Single Institutional Experience   Burnette   Hall GH
                         
    5:30 PM-7:30 PM   1604   Poster   Fludarabine and Mitoxantrone Followed by Yttrium-90 Ibritumumab Tiuxetan in Untreated Patients with Follicular Lymphoma. Long Term Efficacy and Toxicity Results of the FLUMIZ Trial

 

  Zinzani   Hall GH
                         
    5:30 PM-7:30 PM   1612   Poster   PET Evaluation Before Autografting Has a Strong Prognostic Impact in High-Risk, Relapsed Follicular Lymphoma Patients   Ysebaert   Hall GH
                         
    5:30 PM-7:30 PM

 

  1640   Poster   Prior Rituximab Exposure Does Not Appear to Affect Time to Treatment Failure After Radioimmunotherapy   Burnette   Hall GH
                         
    5:30 PM-7:30 PM   1648   Poster   Phase I, Multicenter, Open Label, Dose Escalation of 90yttrium-Ibritumomab Tiuxetan Radioimmunotherapy Using a Modified Regimen for Relapsed or Refractory Follicular or Transformed CD20+ B-Cell Lymphoma   Vaklavas   Hall GH
                         
    5:30 PM-7:30 PM   2005   Poster   Mature Results of BEAM/High-Dose Rituximab Vs BEAM/Yttrium-90 Ibritumomab Tiuxetan (Zevalin®) and Autologous Stem Cell Transplantation (ASCT) for Relapsed CD20+ Follicular and Diffuse Large B-Cell Lymphoma: Survival Outcomes and Risk of Secondary Malignancies   Zipp   Hall GH
                         
Sunday, December 11, 2011            
             
    6:00 PM-8:00 PM   2701   Poster   First Evidence for High Incidence of Complete and Sustained Molecular Remissions and Maintenance of Immune Responses in Patients Receiving Consolidation with Y90 Ibritumomab Tiuxetan (90Y-RIT) Post R-CHOP for Newly Diagnosed Advanced Stage High and Intermediate Risk Follicular Lymphoma   Pennell   Hall GH
                         
    6:00 PM-8:00 PM   3027   Poster   Yttrium-90-Ibritumomab Tiuxetan (Zevalin) in Combination with a Fludarabine-Based Reduced Conditioning Regimen (RIC) Followed by Allogenic Stem Cell Transplantation for Advanced/Aggressive Non-Hodgkin's Lymphoma (NHL): A Prospective, Multicentre, Open Phase II Study   Bouabdallah   Hall GH
                         
    6:00 PM-8:00 PM   3078   Poster   90yttrium Ibritumomab Tiuxetan-BEAM Followed by Autologous Stem Cell Transplantation Significantly Improves Overall Survival After Rituximab Containing Induction Therapy in Patients with High-Risk Aggressive B Cell Non-Hodgkin's Lymphoma   Wondergem   Hall GH
                         
    6:00 PM-8:00 PM   3095   Poster   A Phase I Trial of Zevalin Radioimmunotherapy with High-Dose Melphalan (HDM) and Autologous Stem Cell Transplant (ASCT) for Multiple Myeloma (MM)   Dispenzieri   Hall GH
                         
    6:00 PM-8:00 PM   3107   Poster   Radioimmunotherapy (RIT) with 90yttrium Zevalin Followed by BEAM Conditioning Regimen (Z-BEAM) and Autologous Stem Cell Transplantation (ASCT) for the Treatment of High Risk Relapsed/Resistant Non Hodgkin's Lymphoma (NHL)

 

  Botto   Hall GH
                         
Monday, December 12, 2011            
             
    6:00 PM-8:00 PM   3703   Poster   Yttrium-90-Ibritumomab Tiuxetan and BuCyE High-Dose Chemotherapy Compared with BuCyE Alone As Conditioning Regimen in Patients with B-Cell Non-Hodgkin Lymphoma: IPI Matched Case Control Study At a Single Center   Jo   Hall GH
                         
    6:00 PM-8:00 PM   3713   Poster   Efficacy of 90yttrium-Ibritumomab Tiuxetan in Extranodal Marginal-Zone Lymphoma   Vanazzi   Hall GH
                         
    6:00 PM-8:00 PM   4157   Poster   A Pilot Phase II Study of C-MOPP-R, Ibritumomab Tiuxetan, and Autologous Transplant for Untreated and Relapsed Follicular Lymphoma: Response, Toxicity, and Feasibility   Fesler   Hall GH
                         
About Non-Hodgkin Lymphoma

According to the National Cancer Institute (www.cancer.gov), there are expected to be 66,360 new cases of non-Hodgkin lymphoma diagnosed and approximately 19,320 deaths in the United States in 2011. Non-Hodgkin lymphoma is defined as any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin lymphoma. These types can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing) types, and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.

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 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 lymphoma.

ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer therapy called radioimmunotherapy. ZEVALIN 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 can result 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 hematology and oncology. The Company's strategy is to acquire, develop and commercialize 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 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.

Forward-looking statement – This press release may 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 are based on management's current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, 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 our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new applications to the FDA may not receive approval, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do 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.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

© 2011 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

 

Contact: Spectrum Pharmaceuticals
Paul Arndt, 702-835-6300
Senior Manager, Investor Relations

 

 

Posted: December 2011

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