FDA Needs More Data On IDEC's Rituxan

In a "Biologic License Application Six-Month End of Cycle ReviewLetter," the US Food and Drug Administration is asking IDEC Pharmaceuticals for more information about its anti-CD20 monoclonal antibody Rituxan (rituximab), for the treatment of relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma.

The FDA does not require additional clinical trials for product approval, IDEC said, and the agency has told the company that the data demonstrating safety and efficacy within the non-Hodgkin's lymphoma patient population is sufficient to support licensure.

Data Requested Relates To Production All of the data being requested by the FDA is related to manufacturing topics previously discussed between the agency and IDEC, the company said, noting that it is in the final stages of obtaining the information and expects to submit these additional data within 60 days.