FDA Expands Ibrutinib Approval for Patients with CLL

Earlier today the US FDA announced approval for the expanded use of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL), who carry a deletion in chromosome 17 (17p deletion). This chromosome is often associated with poor responses to standard CLL treatments. Additionally the FDA also approved,

“…new labeling to 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 progression-free survival and overall survival have confirmed the drug’s clinical benefit.”

This approval and new labeling reflect the results of previous clinical studies of CLL patients with 17p deletion. Please look to this blog and our clinical trials page for further developments regarding the use of ibrutinib in patients with CLL.

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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