Two drugmakers withdrew two indications for their drug Imbruvica (ibrutinib) — the treatment for mantle cell lymphoma and marginal zone lymphoma — after a failure to meet endpoints in a phase 3 study.
Janssen, a J&J company, and Pharmacyclics, a AbbVie business, said April 6 that the FDA weighed in on the decision to remove indications for "the treatment of patients with mantle cell lymphoma who have received at least one prior therapy, and for the treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy."
The drug remains approved for adults with chronic lymphocytic leukemia/small lymphocytic lymphoma and Waldenström's macroglobulinemia, and patients 1 and older with chronic graft versus host disease after failure of one or more lines of systemic therapy, according to the FDA.