Zydelig approved by FDA to treat three types of blood cancers

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced approval for Zydelig (idelalisib) to treat patients with three types of blood cancers.



Traditional approval was granted to treat patients whose chronic lymphocytic leukemia has relapsed. The agency granted accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma, or FL, and relapsed small lymphocytic lymphoma, or SLL. The drug is intended to be used in patients who have received at least two prior systemic therapies, according to the agency.



“In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Zydelig’s approval to treat CLL reflects the promise of the breakthrough therapy designation program and represents the FDA’s commitment to working cooperatively with companies to expedite a drug’s development, review and approval.”



Zydelig is designated as an orphan product because it is intended to treat a rare disease.