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FDA Expands Ibrutinib (Imbruvica) Label to Include Chronic Lymphocytic Leukemia

Treatment already approved for mantle cell lymphoma (February 12)

The FDA has expanded the approved use of ibrutinib (Imbruvica, Pharmacyclics) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy.

Ibrutinib works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted ibrutinib accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.

The agency’s approval of ibrutinib for CLL is based on a clinical study of 48 previously treated participants. On average, the participants were diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All study participants received a 420-mg oral dose of ibrutinib until the treatment reached unacceptable toxicity or the disease progressed.

The results showed that nearly 58% of participants had their cancer shrink after treatment (the 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; February 12, 2014.

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