Treats newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+…. NDA 217379, held by Cycle. Nilotinib.
As of Nov 13, 2026, NDA 217379 (Cavhanza), held by Cycle, was first approved by FDA on May 29, 2026, with 1 approved supplement and 1 published complete response letter.
CAVHANZA is a kinase inhibitor indicated for the treatment of: Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. 1.1 Adult Patients with Newly Diagnosed Ph+ CML-CP CAVHANZA is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 14, 2024 | NDA 217379Clinical Pharmacology, Facility Inspections | Unapproved |
| Jul 29, 2026 | Supplement 2Labeling · Standard review | Approved | |
| May 29, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
