- Currently, Abbvie and Janssen's Imbruvica (ibrutinib) is approved for second-line treatment of chronic lymphocytic leukemia (CLL) in patients with the genetic mutation del 17p. The companies are now seeking a first-line treatment indication from the FDA.
- The application to expand the indication to treatment-naive CLL patients is based on phase III results from the RESONATE-2 (PCYC-1115) trial.
- New treatment options are continually needed for CLL because patients with CLL typically relapse and then fail to respond to standard chemotherapy. Therefore, it's good to have additional treatment options.
Imbruvica, which is being jointly developed and commercialized by Pharmacyclics (part of AbbVie) and Janssen Biotech (part of Johnson & Johnson), is broadly used across several indications beyond just CLL, including the treatment of patients with mantle cell lymphoma who have received at least one prior therapy and Waldenstrom's macroglobulinemia.
An expanded indication to include treatment-naive patients would significantly expand the potential treatment pool of CLL patients and bolster the companies' market share.
According to the American Cancer Society, each year about 14,260 people in the U.S. are diagnosed wtih CLL, and about 4,650 people die as a result of the disease.