FDA approves label expansion for oral ibrutinib suspension in all current indications
The FDA has approved a label expansion for ibrutinib (Imbruvica) with an oral suspension formulation for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia, and chronic graft-versus-host disease (cGVHD) after failure on at least 1 line of systemic therapy
Prior to the label expansion, ibrutinib was administered orally in capsules or tablets, once daily. However, data have shown that approximately 5% of patients who receive treatment with a BTK inhibitor for CLL or Waldenström macroglobulinemia may have trouble swallowing.
“Some patients may have trouble swallowing medications, adding another layer of complexity to their treatment journey,” Lisa Nodzon, PhD, ARNP, AOCNP, at Moffitt Cancer Center in Tampa, Florida, said in a news release. “Having multiple formulations of ibrutinib offers prescribers another option when treating adults with CLL/SLL, Waldenström macroglobulinemia, or cGVHD, which could make a difference in their daily lives.”
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