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

Welcome to OncLive On Air®! I’m your host today, Riley Kandel.

OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

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.

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