"Talk to your pharmacist about emerging treatments for your condition."
Zydelig's effectiveness in treating chronic lymphocytic leukemia was vetted through a clinical trial of 220 patients who were given the medicine in combination with Rituxan, another cancer medication, or a placebo and Rituxan.
The combination allowed participants to live up to 10.7 months without the cancer progressing, while the placebo and Rituxan only allowed 5.5 months on average, the FDA reported.
Another study of 123 patients suggested that Zydelig was effective in treating relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma. The results convinced the FDA to approve Zydelig to treat these cancers through its accelerated approval program.
Richard Pazdur, MD, director of the Office of Hematology and Oncology Products for the FDA, said treatments for chronic lymphocytic leukemia improved significantly in the last year.
“Zydelig’s approval to treat [chronic lymphocytic leukemia] 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,” he said.
The FDA reported that Zydelig carries a boxed warning that cites liver toxicity, diarrhea, colon inflammation, lung inflammation and intestinal perforation as potential risks of taking the medication.