NAPSR news: FDA grants regular approval of IMBRUVICA to treat chronic lymphocytic leukemia

IMBRUVICA®, a jointly developed therapy from Pharmacyclics, Inc. and Janssen Biotech received full Approval based on Phase 3 RESONATE™ study data
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WASHINGTON - July 29, 2014 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) administered in the form of capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. IMBRUVICA was also approved to treat CLL patients with del 17 p [1] , a genetic mutation that transpires after a part of chromosome 17 is lost. CLL patients with del 17p are considered to have the poorest prognosis.[2]

The Phase III RESONATE™ study (PCYC-1112-CA) produced data showing significant statistical improvements which propelled the FDA’s decision for the full approval . The study comprised of 373 patients with CLL and 18 patients with small lymphocytic lymphoma (SLL), who received at least one prior therapy.

"IMBRUVICA demonstrated substantial evidence of its superiority over ofatumumab and significant benefit for previously treated CLL patients, while maintaining a favorable safety profile. This FDA approval for IMBRUVICA is a major step toward chemo-free treatment in CLL," said John Byrd, M.D.,* Director, Division of Hematology, The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital & Richard J. Solove Research Institute and lead investigator for RESONATE. "Patients with deletion 17p CLL are at particularly high risk for poor outcomes. Today's approval of IMBRUVICA provides these patients with the only FDA-approved treatment, regardless of whether their disease is treatment naïve or previously treated. I continue to be awed by the duration of my patients' responses to IMBRUVICA and am grateful IMBRUVICA now is available to a broader group of CLL patients."

Chronic lymphocytic leukemia (CLL) is a type of cancer of the white blood cells and occurs when the bone marrow makes too many abnormal white blood cells, or lymphocytes, that never become healthy, infection-fighting cells. It is the second most common form of leukemia in adults and is the most common adult leukemia in the Western world usually affecting the elderly with a median age at diagnosis of 72 years. “We are delighted IMBRUVICA has received full approval by demonstrating its ability to improve progression-free survival and, importantly, overall survival as compared to an approved standard of care, and that IMBRUVICA is now available to all patients with del 17p CLL," said Danelle James, M.D., Vice President, Clinical Development, Pharmacyclics. "Our goal is to provide patients with clinically meaningful treatments. Thanks to the physicians and patients who helped us complete this trial in near record time, today, we have delivered on that goal by bringing IMBRUVICA to an even broader group of patients."

IMBRUVICA is being jointly developed and commercialized by Pharmacyclics, Inc. and Janssen Biotech, Inc. Both companies will continue further research by establishing an extensive clinical development program for IMBRUVICA, which includes Phase 3 study commitments in multiple patient populations.

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