Ibrutinib Approved for Mantle Cell Lymphoma

The United States Food and Drug Administration (FDA) has approved Ibrutinib (Imbruvica) for the treatment of patients with mantle cell lymphoma (MCL). The indication specifies that patients must have received at least one prior therapy.

Mantle cell lymphoma is a rare and aggressive type of cancer that affects the immune cells. Of the non-Hodgkin’s lymphoma cases in the United States, MCL comprises approximately 6% of them.

Ibrutinib is a novel agent that targets an enzyme and inhibits its action in replication and spread of the cancer cells. Since ibrutinib is targeted towards a specific enzyme, it does not tend to cause the extreme side effects associated with standard chemotherapy and/or radiation therapy.

The trial upon which the approval is based included 111 patients with MCL. All patients were given Ibrutinib daily until their cancer progressed or they were not able to tolerate side effects.

  • 66% of patients demonstrated a complete or partial regression of their cancer.
  • Follow-up has not been long enough to determine if there has been an improvement in survival or cancer-related symptoms.

Ibrutinib was approved under the breakthrough therapy designation program.

Patients with MCL who have already received prior therapy may wish to speak with their physician regarding their individual risks and benefits of Ibrutinib.

Reference: United States and Food and Drug Adminstration. FDA approves imbruvica for rare blood cancer. Press release accessed November 15, 2013. Available at: