USFDAApr 27, 2026, 08:06 AM
TERN TERN-701 Receives FDA Breakthrough Therapy Designation
AI Summary
Terns Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TERN-701, an oral allosteric BCR::ABL1 inhibitor. This designation is for adult patients with Ph+ CML in the chronic phase without the T315I mutation, who have been previously treated with two or more TKIs. The BTD is supported by promising data from the Phase 1/2 CARDINAL clinical trial, which demonstrated encouraging rates of major and deep molecular response at week 24, alongside a favorable safety and tolerability profile. The company also noted that the recent agreement for Merck to acquire Terns has the potential to accelerate the advancement of TERN-701 to a pivotal trial.
Key Highlights
- FDA granted Breakthrough Therapy Designation to TERN-701 for Ph+ CML.
- TERN-701 targets adult patients with Ph+ CML without T315I mutation, previously treated with two or more TKIs.
- Designation based on promising data from the ongoing Phase 1/2 CARDINAL clinical trial.
- Trial showed encouraging rates of major and deep molecular response at week 24.
- Observed low incidence of severe adverse events and discontinuations.
- Merck's agreement to acquire Terns is expected to accelerate TERN-701's advancement.