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 | |||||||
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
