U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab as First Non-Chemotherapy Combination Regimen for Patients with Waldenström’s Macroglobulinemia, a Rare Blood Cancer

Latest FDA approval expands label for IMBRUVICA, the only BTK inhibitor indicated for Waldenström’s macroglobulinemia (WM)

IMBRUVICA plus rituximab showed significant improvement in progression-free survival at 30 months and demonstrated superiority versus rituximab monotherapy in WM
“The combination of IMBRUVICA and rituximab provides health care professionals with a new treatment option for patients living with this serious blood cancer,” said Dr. Lia Palomba, hematologist-oncologist at Memorial Sloan-Kettering Cancer Center, New York, and iNNOVATE study investigator. “Before IMBRUVICA, there were no FDA-approved treatment options for patients with Waldenström’s macroglobulinemia, a disease first acknowledged nearly 75 years ago. Today, IMBRUVICA continues to provide an important therapeutic approach in the treatment of this complex disease.”

U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab as First Non-Chemotherapy Combination Regimen for Patients with Waldenström’s Macroglobulinemia, a Rare Blood Cancer | Johnson & Johnson