The FDA approved a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least 1 therapy before. The approval was granted under the FDA’s accelerated approval process to expedite access by patients with CLL to this promising new medication.
In November 2013, the FDA granted accelerated approval to ibrutinib for the treatment of patients with mantle-cell lymphoma (MCL), a rare and aggressive type of hematologic cancer; this approval, too, was for patients who had received at least 1 therapy before.
“Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” said Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The FDA completed its review of Imbruvica’s new indication under the agency’s accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most.”
The approval of ibrutinib for the treatment of patients with CLL was also done under the priority review process of the FDA, based on the demonstration of the drug to have a significant improvement on the safety or efficacy of patients with this serious condition. Ibrutinib also received an orphan drug designation by the FDA.
The new FDA indication for ibrutinib for CLL is based on the results of a clinical trial with 48 previously treated patients with CLL. Patients were diagnosed with CLL an average of 6.7 years before enrolling in the study and had received 4 previous therapies. Patients received oral ibrutinib until disease progression or unacceptable toxicity. Overall response was seen in nearly 58% of the patients, with a response duration of 5.6 months to 24.2 months during the study. Improvements in survival or disease-related symptoms have not been established. The most common side effects reported with ibrutinib include thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper-respiratory tract infection, fatigue, musculoskeletal pain, rash, pyrexia, constipation, peripheral edema, arthralgia, nausea, mouth sores, sinusitis, and dizziness. (February 12, 2014)