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United States : IMBRUVICA (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p

July 30, 2014

The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICAŽ (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. The FDA also approved IMBRUVICA for CLL patients with del 17p,1 a genetic mutation that occurs when part of chromosome 17 has been lost. CLL patients with del 17p are considered to have the poorest prognosis. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics, Inc.

The update to the IMBRUVICA label is based on data from the Phase 3 RESONATE study, which demonstrated IMBRUVICA significantly improved progression-free survival (PFS) and overall survival (OS) versus ofatumumab in patients with previously treated CLL or small lymphocytic leukemia (SLL).

IMBRUVICA was initially approved in February 2014 under Subpart H regulation, the FDA s accelerated approval process, based on data from a Phase 1b/2 study for patients with CLL who have received at least one prior therapy. This indication was based on an overall response rate (ORR). An improvement in survival or disease-related symptoms was not established. In accord with the accelerated approval process, confirmation of clinical benefit in a subsequent Phase 3 study was required, which has resulted in this updated indication for the use of IMBRUVICA in patients with CLL who have received at least one prior therapy and in CLL patients with del 17p.

The RESONATE data expands our understanding of the efficacy and safety of IMBRUVICA to an even greater degree, said John C. 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. This approval is particularly exciting for people with del 17p CLL, considering IMBRUVICA is the first treatment to be approved specifically for this difficult-to-treat patient population.

CLL is a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells. CLL is predominantly a disease of the elderly, with a median age of diagnosis of 72.4 In CLL, the genetic mutation del 17p occurs when part of chromosome 17 has been lost. CLL patients with del 17p have poor treatment outcomes.2 Del 17p is reported in seven percent of treatment-naÏve CLL cases, with approximately 20 to 40 percent of relapsed/refractory patients harboring the mutation.

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Source: TendersInfo (India)

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