IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, today announced that on Thursday, January 20, 2011, it submitted a Post Approval Supplement containing data supporting the removal of the Indium-111 ZEVALIN® pre-treatment imaging evaluation, more commonly referred to as the “bioscan” requirement. This bioscan component currently is required by the FDA as part of the ZEVALIN therapeutic regimen for the treatment of non-Hodgkin’s lymphoma. The ZEVALIN therapeutic regimen requires two administrations of ZEVALIN, the Indium-111 bioscan dose, and the Yttrium-90 therapeutic dose administered 7-9 days later. A single administration of each of these doses takes approximately 10 minutes. The purpose of the bioscan is to pre-determine the distribution of ZEVALIN throughout the body prior to the administration of the therapeutic dose of ZEVALIN, and has no therapeutic effect on the patients.
“We have had several discussions and meetings with the FDA over the past several months to determine exactly what data were necessary to remove the bioscan requirement. We believe that the data we submitted should satisfy the FDA,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Removal of the bioscan eases the burden on patients, doctors, and the healthcare system. First and foremost, patients need to make one less trip to a ZEVALIN administration site and do not have to undergo a scan. Secondly, logistical coordination between the referring oncologist and the administering nuclear medicine or radiation oncology specialist is reduced. Third, it reduces the costs to the healthcare system of administering ZEVALIN by eliminating a costly scan.”
Spectrum Pharmaceuticals markets ZEVALIN in the United States. ZEVALIN is currently approved in more than 40 countries. Of those countries, only three require the bioscan: the United States, Japan, and Switzerland.
Of the more than eight thousand patients who have been treated with ZEVALIN in the United States since its approval in 2002, less than 1% had a true altered bioscan. Additionally, the data the Company submitted suggests that of those patients who had a true altered bioscan and received ZEVALIN treatment appeared to experience safety and efficacy outcomes that were consistent with patients with a normal bioscan.
FDA has up to 60 days to formally accept the submission.
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.
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. Full prescribing information can be found at www.ZEVALIN.com.
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, and 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 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 financial results, 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, the safety and efficacy of ZEVALIN, FUSILEV, apaziquone, and belinostat, 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 trademark of Spectrum Pharmaceuticals, Inc., and TURNING INSIGHTS INTO HOPE™, BELINOSTAT™ and the Spectrum Pharmaceutical logos are trademarks owned by or licensed to Spectrum Pharmaceuticals, Inc.
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