← Back to feed Cavhanza cleared for Philadelphia chromosome-positive CML
Sponsor Cycle Pharmaceuticals
Drug Cavhanza · nilotinib (orally disintegrating tablet)
Indication Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) — chronic phase and accelerated phase More on Cycle Pharmaceuticals ↗ Google News FDA approved Cavhanza (nilotinib) orally disintegrating tablets from Cycle Pharmaceuticals for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). The ODT formulation is designed to be taken without regard to meals or acid-reducing agents (PPIs and H2 antagonists), removing the food-effect and drug-interaction restrictions that constrain the reference-listed nilotinib product (Tasigna).
Read original at drugs.com ↗ Background Drug-class context · Wikipedia Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor, first approved in 2007 as Tasigna (Novartis) for chronic and accelerated-phase Ph+ CML in patients resistant or intolerant to imatinib. It is more potent and more selective than imatinib against BCR-ABL and has activity against most imatinib-resistant BCR-ABL mutations except T315I. The reference product Tasigna is heavily constrained by food-effect and drug-interaction requirements: it must be taken on an empty stomach (no food 2 hours before and 1 hour after each dose), and it interacts with acid-reducing agents (PPIs, H2 antagonists) — which are commonly co-prescribed in CML patients. Cavhanza is a Cycle Pharmaceuticals-developed orally disintegrating tablet formulation of nilotinib engineered to eliminate these restrictions. Approval was granted June 2, 2026.
Source: Wikipedia · CC BY-SA
Topic leukemia
