FDA rejects biotech co.’s non-Hodgkin’s lymphoma treatment
IRVINE, Calif. A biotech company focused on cancer treatments has received a rejection letter from the Food and Drug Administration for its application for a drug to treat non-Hodgkin’s lymphoma.
Spectrum Pharmaceuticals said the FDA rejected its application seeking approval for an additional use of Zevalin (ibritumomab tiuxetan), as a first-line consolidation treatment for NHL. The drug already has approval to treat patients with relapsed or refractory, low-grade or follicular B-cell NHL.
Spectrum said it would submit the additional data the FDA requested by Wednesday.