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  1. OncLive® On Air
  2. S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD
S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD

S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD

OncLive® On Air · Jun 22, 2026

FDA approves a new orally disintegrating nilotinib tablet for CML, improving dosing consistency, safety, and patient convenience.

New CML Drug Formulations Improve Safety by Eliminating Food and Drug Interactions

Alternate TKI formulations, like nilotinib, are engineered to be superior to parent compounds. They remove dietary restrictions (fasting) and interference from acid reducers, ensuring consistent drug exposure. This can reduce adverse effects and improve patient quality of life, moving beyond the simple 'biosimilar' label.

S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD thumbnail

S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD

OncLive® On Air·19 hours ago

Over-the-Counter Acid Reducers Can Silently Sabotage CML Cancer Therapy

Common, OTC acid-reducing drugs can drastically inhibit TKI absorption, sometimes by more than half. This frequently overlooked drug interaction can cause suboptimal responses and treatment failure in CML patients. The lack of patient questioning about OTC use presents a significant and avoidable clinical risk.

S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD thumbnail

S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD

OncLive® On Air·19 hours ago

Improved CML Drug Absorption May Paradoxically Reveal a Drug's Full Toxicity Spectrum

Newer TKI formulations ensure consistent drug absorption, correcting for under-dosing caused by food or other medications. While improving efficacy, this means more patients may experience the drug's known side effects. What seems like new toxicity could be the drug’s true profile, no longer masked by poor absorption.

S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD thumbnail

S17 Ep36: FDA Approval Insights: Orally Disintegrating Nilotinib Tablets for CML: With Michael J. Mauro, MD

OncLive® On Air·19 hours ago