Pharmacyclics, a Sunnyvale, Calif.-based biopharmaceutical company, has launched informCLL, a large, observational, prospective registry that will explore the natural history of chronic lymphocytic leukemia (CLL), examine how Imbruvica (ibrutinib) and other approved targeted therapies are being used to treat patients with CLL and provide a comparison to treatments using conventional chemoimmunotherapy (CIT). Imbruvica is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, and the registry is a joint effort between the companies. Registry enrollment will begin in the first half of 2015.
The CLL registry will enroll more than 1,000 patients with CLL or small lymphocytic lymphoma (SLL) from community and academic institutions across the U.S. Patients participating in the registry should have received treatment with at least one prior therapy or have been determined to have high-risk disease, such as 17p deletion (del 17p), a genetic mutation which occurs when part of chromosome 17 has been lost or deleted and is associated with poor treatment outcomes. Most patients will be receiving treatment with a targeted agent.
"The informCLL registry will provide important insights that will enhance our ongoing CLL development program and is part of our continued commitment to support patients with CLL," said Elizabeth Faust, Ph.D., vice president, medical affairs, Pharmacyclics.
The prevalence of CLL/SLL is approximately 115,000 patients in the U.S, with about 16,000 newly diagnosed patients every year. As this orphan disease frequently progresses following first-line therapy, patients are faced with fewer treatment options and often are prescribed multiple lines of therapy as they relapse or become resistant to treatments.