HORSHAM, PA. February 26, 2024 – Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for Imbruvica® (ibrutinib) with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); Waldenström’s macroglobulinemia (WM); and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
Expert Perspective on the Formulation Expansion
“Some patients may have trouble swallowing medications, adding another layer of complexity to their treatment journey,” said Lisa Nodzon, PhD, ARNP, AOCNP at Moffitt Cancer Center.‡ “Having multiple formulations of Imbruvica offers prescribers another option when treating adults with CLL/SLL, WM, or cGVHD, which could make a difference in their daily lives.”
Clinical Need for Oral Suspension Formulation
Data show that an estimated five percent of patients treated with a Bruton’s tyrosine kinase inhibitor (BTKi) for CLL or WM have potential difficulty swallowing.1 The oral suspension formulation of Imbruvica® provides a benefit compared to other BTKis, offering flexible administration with more options for patients and providers.
Johnson & Johnson’s Commitment to Patient Care
“As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD. Nearly 300,000 patients worldwide have been treated with Imbruvica to date, and we’re continually looking toward the future to help support additional patients,” said Mark Wildgust, PhD, Vice President, Global Medical Affairs, Oncology, Johnson & Johnson Innovative Medicine. “The approval of an Imbruvica oral suspension formulation underscores our commitment in providing innovative, alternate delivery options that address individualized patient needs and allow patients flexibility in how they take their medicine.”
About Imbruvica®
Imbruvica® (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company. Imbruvica® blocks the BTK protein, which is needed by normal and abnormal B cells, including specific cancer cells, to multiply and spread. By blocking BTK, Imbruvica® may help move abnormal B cells out of their nourishing environments and inhibit their proliferation.2,3,4
Imbruvica® is approved in more than 100 countries and has been used to treat almost 300,000 patients worldwide over the last decade. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, spanning more than 11 years evaluating the efficacy and safety of Imbruvica®.
Imbruvica® was first approved by the U.S. FDA in November 2013, and today is indicated for adult patients in four disease areas. These include indications to treat adults with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with or without 17p deletion (del17p); adults with Waldenström’s macroglobulinemia (WM); and adult and pediatric patients aged one year and older with previously treated chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.5
IMPORTANT SAFETY INFORMATION
INDICATIONS
Imbruvica® is a kinase inhibitor indicated for the treatment of:
Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion.
Adult patients with Waldenström’s macroglobulinemia (WM).
Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.
