December 6, 2010

ZEVALIN Demonstrates 35-Month Progression-Free Survival Benefit after Single Dose in Patients with Non-Hodgkin's Lymphoma

Eleven Presentations Including Five Oral Sessions Highlight Strong ZEVALIN Data Including the Nearly Three Year Advantage in Median PFS versus Control Demonstrated in Phase 3 FIT Trial Follow-up

ORLANDO, Fla.--(BUSINESS WIRE)-- Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI) today announced that updated data from the ZEVALIN (ibritumomab tiuxetan) injection for intravenous use Phase 3 First-line Indolent Trial (FIT) released in an oral presentation at the 52nd American Society of Hematology (ASH) Annual Meeting by independent researchers demonstrated that after a median follow-up of 66.2 months, patients with previously untreated follicular non-Hodgkin's lymphoma treated with a standard, single-dose infusion of ZEVALIN as part of the ZEVALIN Therapeutic Regimen after partial or complete response to first-line chemotherapy had a nearly three-year advantage in median progression-free survival (PFS) compared to patients treated with either chemotherapy alone or chemotherapy plus rituximab (49 months versus 14 months).

"ZEVALIN is in my opinion the most effective single drug available with an acceptable hematological toxicity profile for the treatment of patients with low-grade malignant follicular non-Hodgkin's lymphoma," said Anton Hagenbeek, M.D., Ph.D., Professor of Hematology, Academic Medical Center, Amsterdam and principal investigator of the FIT trial who presented the updated data in an oral presentation at ASH. "Hematologists should seriously consider this cost-effective treatment modality, which is relatively easy to administer, for their patients in first remission."

"The compelling five-year follow-up FIT data underscore the strong clinical utility of ZEVALIN for its approved indication of consolidation of first remission in patients with non-Hodgkin's lymphoma," said Rajesh C. Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. "Since obtaining commercial rights to ZEVALIN over a year ago, we have made great strides in broadening the utilization of ZEVALIN, including securing FDA approval as first-line consolidation therapy, establishment of full reimbursement, and inclusion in the National Comprehensive Cancer Network treatment guidelines. These accomplishments further strengthen the ZEVALIN brand and its growth potential," Dr. Shrotriya continued.

Spectrum Pharmaceuticals plans to submit data for consideration to the U.S. Food and Drug Administration to remove the bioscan requirement prior to ZEVALIN administration. Spectrum believes removal of the requirement will further improve the convenience of ZEVALIN administration and thereby further facilitate its adoption as the standard of care in first-line consolidation setting for follicular non-Hodgkin's lymphoma.

Second Follow-Up Data from FIT — Oral Session, ASH Abstract #594

90-Y-Ibritumomab Tiuxetan (ZEVALIN) Consolidation of First Remission in Advanced-Stage Follicular Non-Hodgkin's Lymphoma: Updated Results After a Median Follow-up of 66.2 Months From the International, Randomized, Phase III First-Line Indolent Trial (FIT) in 414 Patients

As published in 2008, results from the first extended follow-up of the FIT trial after a median of 42 months revealed a significant improvement in PFS from the time of randomization with ZEVALIN consolidation compared with control (36.5 versus 13.3 months, respectively; p<0.0001; Morschhauser et al. JCO. 2008; 26:5156-5164).

The multinational, randomized, open-label Phase 3 FIT trial evaluates clinical benefit and safety of a single infusion of ZEVALIN in 414 patients with CD20-positive follicular non-Hodgkin's lymphoma who had achieved a partial response or a complete response after receiving one of the standard first-line chemotherapy regimens.

Patients were randomly assigned to either ZEVALIN treatment (n=207) or observation (n=202) within three months of completing induction chemotherapy (chemotherapy only: 86%; rituximab in combination with chemotherapy: 14%).

FIT-study results at 66.2 months median follow-up (5.5 years)

  ZEVALIN   Control   P-value
    (Months)   (Months)    
Median Progression-Free Survival (PFS) in all patients randomized   49   14   <0.001
PFS Among Patients with Complete Response after Chemotherapy Induction   Median not yet reached at 92 months   32   0.011
PFS Among Patients with Partial Response after Chemotherapy Induction   30   6   <0.001
Time to Next Treatment/Time without need for further treatment   Median not yet reached at 99 months   35   <0.0001

At the 66.2 month analysis, five-year PFS was 47% in the ZEVALIN group and 29% in the control group (p<0.0001). Median PFS in the ZEVALIN group was 49 months versus 14 months in the control group (p<0.001). For all patients, the time to next treatment (as calculated from the date of randomization) differed significantly between the two groups; the median was not reached at 99 months in the ZEVALIN group versus 35 months in the control group (p<0.0001). At current follow-up, no significant difference in incidence of secondary malignancies has been observed, with 16 malignancies reported in the ZEVALIN group versus nine in the control group (P=0.19). Six cases of myelodysplastic syndrome (MDS)/acute myelogenous leukemia (AML) were reported in the ZEVALIN group versus one case in the control group (P=0.062). Following disease relapse on study, patients were treated at the discretion of the investigator with treatments that included, besides chemotherapy, autologous (n=44) or allogeneic (n=4) stem cell transplantation, or ZEVALIN for patients originally assigned to the control group (n=12). Use of ZEVALIN upfront in this study did not appear to affect responses to subsequent treatments given for relapsed disease. The toxicity profile in this study is reflected in currently approved product labeling, which is based on results from this trial.

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.

Full prescribing information can be found at

Important ZEVALIN(R) 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. Patients and healthcare professionals can visit for more information.

About Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is caused by the abnormal proliferation of white blood cells and spreads through the lymphatic system, a system of vessels that drains fluid from the body. NHL can be broadly classified into two main forms: aggressive NHL, a rapidly spreading acute form of the disease; and indolent NHL, which progresses more slowly. Follicular lymphoma is a type of indolent lymphoma. According to the National Cancer Institute's SEER database ( there were approximately 419,533 patients alive with a history of NHL. According to the American Cancer Society, NHL is one of the most common cancers in the United States, accounting for approximately 4% of all cancers. In 2010, an estimated 65,540 people will be diagnosed and approximately 20,210 people will die from the disease.

About Spectrum Pharmaceuticals

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

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 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 drug candidates may not receive approval from the FDA, 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 revenues, 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.

© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700 x 216

Source: Spectrum Pharmaceuticals, Inc.

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