FDA Approves Ibrutinib for CLL
New Drug Approved for Refractory or Relapsed Mantle Cell Lymphoma
The United States Food and Drug Administration (FDA) today announced its approval of ibrutinib (Imbruvica®) for treatment of chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy, according to a press release.
The FDA's decision expands the indication for ibrutinib, which received accelerated approval from the FDA in November 2013 to treat patients with mantle cell lymphoma who have received at least one prior therapy.
Similarly, for the CLL indication, ibrutinib was granted priority review and orphan-product designation.
The FDA based their accelerated approval of ibrutinib for CLL on results of a clinical study involving 48 participants who had previously received an average of four therapies and were diagnosed an average of 6.7 years before study enrollment. Researchers administered 420 mg of ibrutinib orally until unacceptable toxicity occurred or until the disease progressed.
According to the release, the cancer shrunk in 58% of participants after treatment, and duration of response ranged from 5.6 to 24.2 months; however, results did not firmly establish a correlation between treatment and improvement in survival or disease-related symptoms.
Common side effects of ibrutinib included thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper respiratory infection, musculoskeletal pain, rash, pyrexia, constipation, peripheral edema, arthralgia, nausea, stomatitis, sinusitis, and dizziness.
“Today's approval provides an important new treatment option for [patients with CLL] whose cancer has progressed despite having undergone previous therapy,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in the release. “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.”