The FDA has accepted an application for XS003, a new biosimilar of nilotinib (Tasigna), a standard treatment for chronic myeloid leukemia (CML). Developed by Xspray Pharma using its proprietary HyNap technology, XS003 is designed to improve upon the original drug’s formulation and patient convenience.
Clinical data show that XS003 achieves bioequivalence to nilotinib at less than half the dose, which may reduce exposure-related side effects. One of the key advantages is its significantly reduced food effect—29% compared with 82% for the reference drug. This means XS003 can potentially be taken with or without food, while Tasigna must currently be taken on an empty stomach to avoid dangerous increases in blood concentration.
The ability to eliminate fasting requirements could greatly improve patient adherence and safety, especially by lowering the risk of QTc prolongation, a heart rhythm issue linked to nilotinib. In addition, XS003 demonstrates improved dose linearity, allowing more predictable dose adjustments during therapy.
A Phase 1 clinical study (NCT07138352) evaluated a single 192 mg dose of XS003 in healthy adults under both fasting and fed conditions. The results confirmed comparable pharmacokinetic and safety profiles to nilotinib, supporting its potential as a safer and more convenient alternative for patients with CML.