HORSHAM, Pa. — Janssen Biotech on Wednesday announced the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. Imbruvica was first approved in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Both indications are based on an overall response rate. An improvement in survival or disease-related symptoms has not been established.
Imbruvica is the first once-daily, single-agent, oral Bruton's tyrosine kinase inhibitor for patients with CLL who have received one prior therapy and is being jointly developed and commercialized by Janssen and Pharmacyclics. Both indications were granted priority review and were approved under the FDA's accelerated approval program; in addition, Imbruvica is one of the first medicines with the FDA's Breakthrough Therapy Designation to receive U.S. approval.
According to the American Cancer Society, CLL accounts for about one-third of all new cases of leukemia.
CLL is a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells. CLL is an orphan disease (which is defined as a disease impacting fewer than 200,000 Americans3) and is primarily diagnosed in those over 70 years old. In the U.S., an estimated 16,000 people are diagnosed with CLL each year and it is estimated that nearly 4,600 will unfortunately die due to this disease. The U.S. prevalence of CLL is approximately 114,500 people.
"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," stated John Byrd, 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 pivotal CLL trial PCYC-1102-CA.+
"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," commented Craig Tendler, VP Late-stage development and global medical affairs for oncology, Janssen. "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."
Five specialty pharmacies have been authorized to dispense Imbruvica, including Avella Specialty Pharmacy, Biologics, Diplomat Specialty Pharmacy, Onco360 and Total Life Care.
“Relapsed or refractory chronic lymphocytic leukemia can be challenging to treat and therapy options currently available are not ideal for all patients,” noted Gary Rice, VP clinical services at Diplomat. “Imbruvica … represents a major achievement in drug development and an important option for patients with this disease.”
“It is truly exciting to hear of such promising potential in a drug that could improve the lives of so many individuals,” stated Leslie Yendro, VP business development of Avella. “Along with providing access to Imbruvica, Avella provides comprehensive support and education to patients that receive this therapy.”