Imbruvica Receives New Indication
January 28, 2019 – The U.S. FDA has approved a new indication for Imbruvica® (ibrutinib) injection, manufactured by AbbVie and Pharmacyclics. Under the new indication, Imbruvica is now approved for use in combination with Genentech’s Gazyva® (obinutuzumab) to provide first-line treatment for adult patients who have chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
CLL accounts for approximately 25% of all new cases of leukemia diagnosed in the United States and typically affects individuals who are at least 40 years of age. The primary distinction between CLL and SLL is the location of the cancer. Typically, CLL is identified in the bloodstream and bone marrow, while SLL occurs primarily in the lymph nodes.
Previously, Imbruvica was indicated as a monotherapy for initial treatment of CLL/SLL. In clinical studies, patients who received Imbruvica and Gazyva experienced a 77% reduction in risk of death or disease progression compared to patients who received Gazyva plus chlorambucil. High-risk patients saw an 85% reduction with Imbruvica plus Gazyva.
Recommended dosing under the new indication is 420mg taken by mouth once daily until disease progression or unacceptable toxicity. Imbruvica is also indicated to treat mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic graft versus host disease (cGVHD).