U.S. Food and Drug Administration (FDA) approved AbbVie’s, Janssen’s Imbruvica (ibrutinib) combined rituximab (Rituxan) for treating adult patients with Waldenström’s macroglobulinemia (WM).
With this approval, the Imbruvica prescribing information now includes combination use with rituximab, representing the first and only chemotherapy-free combination treatment specifically indicated for the disease. Imbruvica was first approved as a single agent therapy for WM in 2015. Imbruvica is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
Thorsten Graef, Head of Clinical Development at Pharmacyclics LLC, an AbbVie company said that the result of robust clinical development program got the approval, and ensures their commitment to exploring the full potential of Imbruvica for treating patients with diseases that have great unmet medical need.
Craig Tendler, Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, said: “This label update builds upon the established efficacy and safety of IMBRUVICA in the frontline treatment of patients with CLL/SLL, as a monotherapy or in combination with other treatments.”
“Ibrutinib has significantly advanced the treatment of Waldenström’s macroglobulinemia. The approval of ibrutinib and rituximab has added a new option for many Waldenström’s patients,” said Steven P. Treon, Director of the Bing Center for Waldenström’s Macroglobulinemia at the Dana-Farber Cancer Institute, Associate Professor at Harvard Medical School, and lead investigator of the Imbruvica Phase 2 clinical trial which served as the basis for its January 2015 FDA approval.