Janssen-Cilag International NV has announced the submission seeking approval for an indication extension of IMBRUVICA (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). The extended indication is for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell transplant (transplant).
Ibrutinib: A Once-Daily Oral Medication for BTK Inhibition
Ibrutinib, a once-daily oral medication that blocks the BTK protein, is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. Since its first approval by the European Commission (EC) in 2014, ibrutinib has been indicated for a range of conditions, including previously untreated chronic lymphocytic leukemia (CLL), adult patients with CLL who have received at least one prior therapy, relapsed or refractory MCL, and Waldenström’s macroglobulinaemia (WM).
Expanding the Use of IMBRUVICA in Lymphoma Treatments
The submission for an indication extension marks a significant step in expanding the use of IMBRUVICA in the treatment of lymphoma. If approved, the combination therapy with R-CHOP will provide a new option for adult patients with untreated MCL, potentially improving treatment outcomes and offering an alternative approach to autologous stem cell transplant-eligible patients.-Fineline Info & Tech
