FDA Expands Imbruvica Label to Include Chronic Lymphocytic Leukemia


The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with chronic lymphocytic leukemia who have received at least one previous therapy.

The FDA's announcement is good news for people with CLL, a rare blood cancer that is newly diagnosed in over 15,000 Americans every year. The disease is also responsible for about 4,580 deaths annually.

Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. The FDA previously granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma in late 2013.

New drug shows promise for treatment

"Today’s approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research in a statement. "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 FDA’s accelerated approval of Imbruvica for CLL is based on a clinical study of 48 previously treated patients. On average, these patients had been diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All participants received a 420 mg orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed. Results showed nearly 58 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 5.6 to 24.2 months.

An improvement in survival or disease-related symptoms has not been established.

Source: FDA

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