Kura Oncology
FDA Approval Strengthens Kura’s Leadership and Drives Momentum to Frontline AML
Key Highlights
- KOMZIFTITM (ziftomenib) receives FDA approval: The first targeted, once-daily oral therapy for adult patients with relapsed/refractory NPM1-mutant AML. Approval based on strong efficacy and safety profile, notably with no Boxed Warning for QTc prolongation or Torsades de Pointes – a class-differentiating benefit risk profile.
- Expansion to frontline AML: Kura aims to advance KOMZIFTI to the broader AML population, potentially supporting up to 50% of AML patients across multiple genetic subtypes. Kura will share P1 data from the KOMET-007 trial at the 2025 ASH Annual Meeting in December and recently initiated its pivotal Phase 3 KOMET-017 trial, evaluating KOMZIFTI for frontline AML.
- Advancing next-generation FTIs: At ESMO 2025, Kura presented encouraging early data for darlifarnib, its next-generation FTI designed to overcome resistance mechanisms to targeted therapies. Darlifarnib’s potential combinations with TKIs, PI3Kα inhibitors and KRAS inhibitors could benefit up to ~200,000 patients annually across multiple solid tumor types.
- Key upcoming milestones:
- Frontline AML data on menin inhibitor combinations at ASH 2025
- Dose-escalation data of darlifarnib + cabozantinib in advanced RCC (2026)
- Preliminary data of darlifarnib + adagrasib in KRASG12C-mutated solid tumors (2026)