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.