J&J Receives FDA Approval For CLL Treatment Imbruvica
Johnson & Johnson’s Janssen Biotech today announced it has won U.S. Food and Drug Administration (FDA) approval for its chronic lymphocytic leukemia (CLL) treatment Imbruvica (ibrutinib) capsules. Imbruvica was first approved in November of last year for the treatment of mantle cell lymphoma (MCL).
Imbruvica is jointly developed by Janssen and Pharmacyclics Inc. as the first single agent and once-daily oral Bruton’s tyrosine kinase (BTK) inhibitor for patients with CLL who have undergone one prior therapy for the disease. Imbruvica works by targeting and blocking BTK protein to inhibit cancer cell survival and further spread. No improvement in survival or disease related symptoms has yet been established for the treatment.
Janssen Late-Stage Development and Global Medical Affairs for Oncology Vice President Craig Tendler, M.D., said, “The speed at which we were able to bring Imbruvica to this point epitomizes the sense of urgency that drives oncology drug developers to bring important new medicines to patients in need. We’re delighted and proud of today’s approval, because it represents our commitment to making a difference for patients. We appreciate the ongoing collaboration between the companies and the FDA, which made this possible.”
CLL is a slow growing cancer of the blood which affects white blood cells called lymphocytes, usually B cells. The disease is primarily diagnosed in patients over 70 years of age. CLL affects an estimated 114,500 people in the U.S., with approximately 16,000 people diagnosed annually. An estimated 4,600 of patients die from the disease every year.
“CLL is a challenging disease and many physicians switch their patients from therapy to therapy as their disease relapses. There has been a significant need for new alternatives for these patients. The approval of Imbruvica provides a new, once-daily oral therapy option for physicians,” said John C. Byrd, director of the Division of Hematology in The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital & Richard J. Solove Research Institute. Director Byrd is also the lead investigator for the pivotal CLL trial PCYC-1102-CA.
The drug’s approval for both indications was based on patients’ overall response rate (ORR). Both CLL and MCL indications were granted priority review and accelerated approval. Imbruvica is one of the first drugs with FDA Breakthrough Therapy Designation to win approval in the U.S.
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