Thursday, July 30, 2015

Newly approved drug for rare blood cancer shows sustained benefit for 2 years

In continuation of my update on Ibrutinib

We know that, Ibrutinib   also known as PCI-32765 and marketed under the name Imbruvica) is an anticancer drug targeting B-cell malignancies. It was approved by the US FDA in November 2013 for the treatment of mantle cell lymphoma and in February 2014 for the treatment of chronic  lymphocytic leukemia  It is an orally-administered, selective and covalent inhibitor of the enzyme Bruton's tyrosine kinase (BTK)  Ibrutinib is currently under development by Pharmacyclics, Inc and Johnson & Johnson'sJanssen Pharmaceutical division for additional B-cell malignancies including diffuse large B-cell lymphoma and multiple myeloma


The most recent results from a clinical trial show that ibrutinib, a newly approved drug for Waldenstrom's Macroglobulinemia, continued to control the rare blood cancer, with 95 percent of patients surviving for two years, report investigators from Dana-Farber Cancer Institute.

The median overall response rate was 91 percent after a median of 19 months of treatment, and in 69 percent of patients the cancer had not worsened two years after beginning treatment. When the cancer did progress, it began at a median time of 9.6 months after the start of treatment. The results are reported in The New England Journal of Medicine.

An earlier analysis of data from this phase 2 multicenter study supported the Food and Drug Administration's approval in January of ibrutinib as the first and only treatment for Waldenstrom's, a rare form of lymphoma that affects about 1,500 people annually in the United States.

"These findings herald a new era for the treatment of Waldenstrom's Macroglobulinemia, and show how genome sequencing can lead to the discovery of cancer mutations that can be specifically targeted by new therapies," said first author Steven Treon, MD, PhD, director of the Bing Center for Waldenstrom's Macroglobulinemia at Dana-Farber.

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