Biotech company Spectrum Pharmaceuticals has submitted a Post Approval Supplement to the FDA asking the agency to remove the bioscan requirement on the administration of its non-Hodgkin's lymphoma drug Zevalin.
Zevalin is used to treat new cases of follicular non-Hodgkin's lymphoma as well as relapsed/refractory low-grade or follicular B-cell non-Hodgkin's lymphoma. Currently, the drug regimen consists of two injections, the first, an Indium-111 bioscan dose to pre-determine the distribution of Zevalin throughout the body, followed by the Yttrium-90 therapeutic dose, seven to nine days later.
After several meetings with the FDA, Spectrum submitted a Post Approval Supplement on Jan. 20, applying for the removal of the Indium-111 bioscan dose requirement. Spectrum argued that only 1 percent of the 8,000 patients treated with Zevalin in the U.S. have had a true altered bioscan. According to Spectrum, Japan and Switzerland are the only other countries (out of 40 total) that have approved Zevalin but require a bioscan dose prior to the therapeutic injection.
Spectrum argued that eliminating the required bioscan would require one less hospital visit and facilitate coordination between physicians, while also reducing healthcare costs. According to the Irvine, Calif. based-Spectrum, the FDA has 60 days to approve the company's application.