Kura Oncology's Ziftomenib Receives FDA Breakthrough Designation for NPM1-Mutant AML
Kura Oncology, has received Breakthrough Therapy Designation from FDA for their experimental drug, ziftomenib. This designation is for treating patients with relapsed or refractory NPM1-mutant acute myeloid leukemia (AML).
Breakthrough Therapy Designation is granted to drugs that show significant promise in treating serious conditions and can expedite their development and review processes.
Ziftomenib is an oral investigational drug designed to target the interaction between the menin and KMT2A/MLL proteins.
It’s taken once daily, with a recommended dose of 600 mg for Phase 2 trials. In current Phase 1 studies, it has shown promise, achieving a 35% complete remission rate in patients with NPM1-mutant acute myeloid leukemia (AML).
The drug is generally well-tolerated, with side effects aligning with the patients' underlying conditions.
In addition to Breakthrough Therapy Designation, ziftomenib has also received Orphan Drug Designation from the FDA, underscoring its potential.
