FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD

In today’s episode, we spoke with Michael J. Mauro, MD, an attending physician at Memorial Sloan Kettering Cancer Center in New York, New York.

In our exclusive interview, Dr Mauro discussed the orally disintegrating tablet formulation of nilotinib (Cavhanza) and its recent June 2026 FDA approval for patients with chronic myeloid leukemia (CML). After diving into the approval itself and the data that supported it, Mauro discussed why the approval is significant and which patients it will benefit most. In addition to covering the approval, Mauro shed light on what is to come for biosimilars and alternate formulations in the greater CML treatment paradigm.