Imbruvica Recieves Regular Approval by US FDA in Chronic Lymphocytic Leukemia and CLL patients with del 17p
July 28, 2014
(Horsham, PA) – The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for IMBRUVICA® (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, 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."
"We're very pleased this approval came swiftly," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development, LLC. "These Phase 3 results reinforce the data on which the original approval was granted; they also offer greater clinical understanding of the impact of efficacy related to progression-free and overall survival and, more importantly, the safety of IMBRUVICA in this patient population."
Data from this study were recently presented during an oral session at the 50th annual meeting of the American Society of Clinical Oncology (ASCO), featured in the official ASCO press program and simultaneously published online in the New England Journal of Medicine. In January 2014, the RESONATE trial was halted early because results showed a statistically significant difference in PFS, the primary endpoint of the study, as well as in OS, a key secondary endpoint at the time of this interim analysis.
Janssen and Pharmacyclics are continuing an extensive clinical development program for IMBRUVICA, including Phase 3 study commitments in multiple patient populations.
The recommended dose of IMBRUVICA for CLL is 420 mg (three 140 mg capsules) orally once daily.
About IMBRUVICA
IMBRUVICA was one of the first therapies to receive U.S. approval via the FDA's Breakthrough Therapy Designation. IMBRUVICA works by blocking a specific protein called Bruton's tyrosine kinase (BTK). The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread., IMBRUVICA targets and blocks BTK, inhibiting cancer cell survival and spread.
Janssen and Pharmacyclics are striving to make the process of obtaining IMBRUVICA and navigating insurance benefits easy for patients. The YOU&i Access™ program is designed specifically for patients who are prescribed IMBRUVICA and provides personalized attention coupled with access services designed to make obtaining medication simple and convenient for patients and those involved in their care.
This includes a YOU&i Access™ Instant Savings program, which provides co-pay support and benefits information to eligible commercially-insured patients. Patients can access the program by contacting 1-877-877-3536, option 1 or by visiting imbruvica.com.
About Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit imbruvica.com.
Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson & Johnson dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world. Follow us on Twitter at www.twitter.com/JanssenUS.
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