GlaxoSmithKline says Bexxar cancer drug gets strong support
GlaxoSmithKline PLC and Corixa Corp said a US Food and Drug Administration panel strongly supported their radioimmunotherapy drug Bexxar, which the two companies are jointly developing.
The FDA Oncologic Drugs Advisory Committee voted 10-3 in support of the efficacy of Bexxar therapy in treating some patients and unanimously supported its clinical use in low-grade and transformed low-grade non-Hodgkin's lymphoma, a form of cancer that affects the blood, bone marrow and lymphatic tissues.
"The FDA is not bound by the committee's action, but often takes its recommendations into consideration when determining marketing approval of a new product", the companies said in a joint statement.
The new Prescription Drug User Fee Act goal date for the FDA to complete its review of Bexxar is May 2, 2003.
The therapy is the only one that allows for the delivery of a predictable amount of radiation to each patient dependent on circumstances such as tumour size.






