Terns Pharmaceuticals Secures FDA Breakthrough Therapy Designation for TERN-701 in CML
Terns Pharmaceuticals, Inc. has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration for TERN-701, a novel oral allosteric BCR::ABL1 inhibitor.
The designation is for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase without the T315I mutation who have previously been treated with two or more tyrosine kinase inhibitors (TKIs).
BTD is granted to accelerate the development and review of therapies that address serious conditions and unmet medical needs, based on early clinical evidence indicating potential improvement over existing treatments.
The designation is supported by data from the ongoing Phase 1/2 CARDINAL trial, where TERN-701 demonstrated encouraging efficacy. Patients showed promising rates of major and deep molecular responses at 24 weeks, including those with high disease burden and prior exposure to multiple therapies.
The treatment has also shown a favourable safety profile, with most adverse events reported as low grade and a low rate of severe events or discontinuations.
Additionally, the planned acquisition of Terns Pharmaceuticals by Merck & Co. is expected to support further clinical development and accelerate progress towards late-stage trials.
