FDA Expands Use of Imbruvica to Include CLL Patients with 17p Deletion

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Well ahead of schedule, the US Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), associated with poor responses to standard treatment for CLL.

Imbruvica received a breakthrough therapy designation for this use.

The FDA has also approved new labeling that will reflect that Imbruvica’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining two other endpoints, progression-free survival and overall survival, have confirmed the drug’s clinical benefit.

A type of non-Hodgkin lymphoma, CLL is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells (B lymphocytes). The National Cancer Institute estimates that almost 16,000 Americans will be diagnosed and 4,600 will die from CLL in 2014.

Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide.

"We continue to see advances in the availability of therapies to treat chronic lymphocytic leukemia, especially for difficult-to-treat patient populations," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. "Imbruvica is the fourth drug approved to treat CLL that received a breakthrough therapy designation, reflecting the promise of the breakthrough therapy designation program and demonstrating the FDA’s commitment to working cooperatively with companies to expedite the development, review and approval of these important new drugs."

The other three drugs approved to treat CLL that received breakthrough designations are Gazyva (obinutuzumab) in November 2013, Arzerra (ofatumumab) in April 2014 and Zydelig (idelalisib) in July 2014. Imbruvica’s application for accelerated approval to treat CLL did not receive breakthrough therapy designation.

Today’s actions for Imbruvica by the FDA are based on a clinical study of 391 previously treated patients, 127 of whom had been diagnosed with CLL with 17p deletion.

Participants were randomly assigned to receive Imbruvica or Arzerra until disease progression or side effects became intolerable. That trial was halted early following a pre-planned interim analysis showed Imbruvica-treated participants experienced a 78 percent reduction in risk of disease progression or death (progression-free survival). Results also showed a 57 percent reduction in risk of death (overall survival) in participants treated with Imbruvica. Of the 127 participants who had CLL with 17p deletion, those treated with Imbruvica experienced a 75 percent reduction in risk of disease progression or death.

Approval today comes over two months ahead of schedule for this indication.

Source: FDA

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