(HNGN) – The U.S. Food and Drug Administration today approved Zydelig, a drug to treat patients with three types of blood cancers.
Zydelig can be used to treat patients whose chronic lymphocytic leukemia (CLL) has relapsed. Additionally, the drug can also be used in combination with Rituxan for patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions. This is the fifth cancer medication that has been approved by the FDA and third drug approved to treat CLL specifically.
The drug can also be used to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL), another type of non-Hodgkin lymphoma. The FDA has also deemed Zydelig appropriate to be used in patients who have received at least two prior systemic therapies.
“In less than a year, we have seen considerable progress in the availability of treatments for chronic lymphocytic leukemia,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press statement. “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.”