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Friday, March 29, 2013

“Breakthrough” Therapy for Lymphoma and CLL

By Richard C. Frank, MD

lab tech

“Everyone always talks about when you have cancer, well if you live long enough there might be a miracle drug that comes out that’s going to go save you. In this instance, I had something that really came along and did the trick.” These are the words of a patient with advanced chronic lymphocytic leukemia treated with the promising new medicine for blood cancers, called Ibrutinib.

Ibrutinib is a promising new medicine for cancers derived from the B-lymphocyte. These include chronic lymphocytic leukemia (CLL) and two types of non-Hodgkin’s lymphoma: mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM). All three of these cancers are very difficult to cure.

Ibrutinib  is a “targeted therapy,” and therefore, has few of the unwanted side effects of chemotherapy. Early phase clinical trials with Ibrutinib for the treatment of advanced cases of CLL and NHL have been hailed as “remarkable” by many oncologists. As a result, the US Food and Drug Administration recently granted “Breakthrough Therapy Designation” for Ibrutinib to treat MCL and WM.  This designation should help speed FDA approval of Ibrutinib once the clinical studies with the drug are completed (and if it continues to live up to its promise).

Although not given the Breakthrough designation for CLL, the drug’s activity for CLL has also been remarkable. In early phase clinical testing, over 80% of patients with CLL or SLL (small lymphocytic lymphoma) whose disease has grown despite all available treatments have experienced major disease regression with few side effects.  Furthermore the cancer control is lasting years in most cases.

A pivotal clinical trial comparing Ibrutinib with the antibody therapy Ofatumumab (Arzerra) is ongoing across the nation and will ultimately determine if Ibrutinib becomes approved for the treatment of advanced CLL. Other CLL trials are testing the use of Ibrutinib as the first treatment for the disease, with or without chemotherapy.

Ibrutinib appears to be an extremely promising new therapy for NHL and CLL, potentially affecting millions of patients around the world. Any patient with CLL or lymphoma, especially MCL and WM should inquire with their oncologists about clinical trials with Ibrutinb that may be accessible to them. Visit www.clinicaltrials.gov to find cancer clinical trials.

Posted by: Richard C. Frank, MD at 7:57 am

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