Spectrum Pharmaceuticals has completed the transaction acquiring control of RIT Oncology, LLC, to commercialize Zevalin ([90Y]-ibritumomab tiuxetan) in the
Zevalin is currently approved for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL), including patients who have rituximab-refractory follicular NHL. The drug is also is under review by the FDA for use as a first line consolidation therapy for patients with NHL.
“We are excited to have 100% ownership of Zevalin,” said Rajesh C. Shrotriya, M.D., chairman, chief executive officer, and president of Spectrum Pharmaceuticals. “Recent clinical data have dramatically underscored the clinical benefits of Zevalin in NHL. We believe that approval of the sBLA for first-line consolidation therapy, which is based on the Phase III FIT data, anticipated regulatory and reimbursement changes, combined with our marketing efforts, will substantially improve patient access to Zevalin.”
“The anticipated FDA approval of the sBLA for Zevalin on or before the July 2, 2009 PDUFA action date will allow for the label to address a substantially larger patient population,” added Dr. Shrotriya. “We expect our commercial launch program to be fully in place by the anticipated approval of the additional indication for Zevalin in July.”
Zevalin was developed by Idec (now Biogen Idec) and was the first radioimmunotherapeuty drug approved by the FDA to treat cancer.