The FDA¿s Oncologic Advisory Committee (ODAC) meets today with briefing papers in hand that favor a recommendation for approval of Zevalin (ibritumomab tiuxetan), IDEC Pharmaceutical Corp.¿s radiolabeled antibody for low-grade, follicular, CD20-positive transformed, relapsed or refractory, B-cell non-Hodgkin¿s lymphoma.
Briefing documents posted on the agency¿s web site summarized clinical data and suggested the drug is effective, with a few provisos.
¿The anti-tumor activity observed is clinically significant but also associated with significant toxicity, which in a small proportion of subjects may be associated with serious morbidity and/or preclude the ability to deliver adequate dose intensity of salvage therapy,¿ says one document. But, it said, Zevalin ¿has demonstrated anti-tumor activity in a heavily pretreated population.¿
Zevalin would be used with Rituxan (rituximab), San Diego-based IDEC¿s nonradiolabeled chimeric antibody.
ODAC today also will consider Baltimore-based Guilford Pharmaceutical Inc.¿s supplemental new drug application for the Gliadel wafer, a biopolymer product approved for recurrent malignant brain cancer. Guilford wants approval for newly diagnosed malignant glioma.
IDEC¿s stock (NASDAQ:IDPH) closed Monday at $56.15, down $1.46. Guilford¿s shares (NASDAQ:GLFD) ended the day at $10.24, down 71 cents. ¿ Randall Osborne