FDA expands indication for Imbruvica

FLINT, Mich. — Diplomat Pharmacy announced Thursday that the Food and Drug Administration has approved an expanded indication of Imbruvica (ibrutinib) for the treatment of Waldenström’s macroglobulinemia (WM). The drug was granted expanded approval under the breakthrough therapy designation.

 

WM is a type of non-Hodgkin lymphoma that begins in the body’s immune system. For patients living with WM, abnormal blood cells grow within bone marrow, lymph nodes, liver and spleen which then overproduce a protein known as immunoglobulin M. Imbruvica treats the disease by blocking the enzyme that supports the growth and division of the abnormal blood cells. According to the American Cancer Society, 1,000–5,000 cases of WM are diagnosed each year, with the average age of diagnosis in the mid-60s.

 

“We are pleased to continue to be a part of the narrow distribution network for Imbruvica,” said Gary Kadlec, president of Diplomat. “The expanded indication will allow Diplomat to provide care and support for a previously underserved patient population. Our high-touch model and patient-centric approach to care supports our commitment to administering this therapy in accordance with our high standards.”

 

Diplomat is currently distributing Imbruvica for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia. Imbruvica was approved by the FDA in November 2013 under the breakthrough therapy designation for the treatment of MCL in patients who have received prior therapy for the disease. Imbruvica was granted expanded approval for the treatment of CLL in patients who have received at least one prior therapy for the disease in February 2014 and for treatment of CLL in patients with 17p deletion in July 2014.