Healthcare Industry News: ZEVALIN
News Release - November 3, 2009
ZEVALIN(R) Receives Positive Reimbursement Ruling Using Average Sales Price (ASP) MethodologyZEVALIN Was Recently Approved by the FDA 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
IRVINE, Calif., Nov 3--(HSMN NewsFeed)--Spectrum Pharmaceuticals (NasdaqGM: SPPI ), a commercial-stage biotechnology company with a primary focus in oncology, today announced that the Centers for Medicare & Medicaid Services (CMS) finalized a policy to allow reimbursement for ZEVALIN® (ibritumomab tiuxetan), a CD20-directed radiotherapeutic antibody, in the Hospital Outpatient Prospective Payment System, based on the Average Sales Price (ASP) methodology applicable to other injectable drugs and biologicals. This reimbursement methodology will go in to effect January 1, 2010.
“We are pleased with the CMS policy ruling, as it represents an important milestone toward establishing a consistent reimbursement standard for ZEVALIN,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We believe that securing ASP methodology for ZEVALIN removes a significant historical barrier to its use. This ASP methodology has until now been widely used for injectable chemotherapy drugs and as such, there is high familiarity with this reimbursement standard.”
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.
Patients and healthcare professionals can visit http://www.ZEVALIN.com for more information.
About Spectrum Pharmaceuticals
We are a commercial-stage biotechnology company with a focus in oncology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our 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 include but are not limited to statements that relate to our 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 our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of ZEVALIN, establishing a consistent reimbursement standard for 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 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.® and ZEVALIN® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its subsidiaries. The Spectrum Pharmaceuticals logo, TURNING INSIGHTS INTO HOPE™ and ZEVALIN logo are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Source: Spectrum Pharmaceuticals
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