Cancer Rx Granted Accelerated FDA Approval Path

Ibrutinib is designed to treat mantle cell lymphoma and Waldenstrom's macroglobulinemia

February 14, 2013 / Author:  / Reviewed by: Joseph V. Madia, MD

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(dailyRx News) The US Food and Drug Administration has given ibrutinib an accelerated pathway to approval. Ibrutinib is an investigational drug designed to treat two lymphomas.

Lymphomas are cancers that develop in the body’s lymphatic system, an important part of the immune system.

Ibrutinib has been granted two Breakthrough Therapy Designations to treat mantle cell lymphoma (MCL) that no longer responds to treatment and Waldenstrom's macroglobulinemia (WM).

"Ask your oncologist about clinical trials or visit clinicaltrials.gov."

MCL is a fast-growing type of B-cell non-Hodgkin's lymphoma (NHL) that usually strikes older adults. About 5,000 Americans are diagnosed with MCL every year.

Waldenstrom's macroglobulinemia is a rare lymphoma for which there is currently no effective treatment. The condition affects about 1,500 Americans every year.

Both of these diseases appear in the B cells, which are part of a group of white blood cells called lymphocytes.

According to the FDA, Breakthrough Therapy Designation speeds up the development and review time for new therapies that preliminary clinical evidence indicates may be effective in treating serious or life-threatening diseases.

Ibrutinib was designed to specifically target and selectively inhibit an enzyme called Bruton's tyrosine kinase (BTK). Through a number of different actions, BTK helps malignant B cells to survive.

The effectiveness and safety of ibrutinib alone or in combination with other treatments is being studied in various blood cancers, including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, Waldenstrom's macroglobulinemia and multiple myeloma.

Currently, ibrutinib is being studied in 27 clinical trials, including five Phase III trials.

Ibrutinib is being developed collaboratively by Janssen Biotech, Inc. and Pharmacyclics.