TERN-701 Earns FDA Breakthrough Therapy Designation in Ph+ CML
The investigational BCR::ABL1 inhibitor TERN-701 has been granted FDA breakthrough therapy designation for adults with Philadelphia chromosome (Ph)-positive chronic myeloid leukemia (CML) in chronic phase who have progressed after at least two prior tyrosine kinase inhibitors (TKIs), based on interim data from the phase 1/2 CARDINAL trial showing high major molecular response rates and a manageable safety profile.
Malignant pleural effusion (MPE) is a common complication in lung cancer and other malignancies. This cross‑sectional study assessed the diagnostic utility of pleural fluid CA‑125 and CEA versus their serum counterparts in patients with pleural effusion. Sixty‑two patients (52% malignant) were evaluated. Pleural fluid CEA (cut‑off <5.3 ng/ml) and CA‑125 (cut‑off <345.6 U/mL) achieved 83.3% and 90% sensitivity, 78.6% and 85.7% specificity, and AUCs of 0.810 and 0.879, respectively. Serum markers had lower performance. Pleural fluid CA‑125 and CEA were the most effective indicators for diagnosing lung‑cancer‑associated malignant pleural effusion.
This agent represents a highly selective, orally available allosteric inhibitor that may offer superior efficacy, safety, and convenience than existing TKIs, providing an important new therapeutic option for patients who have failed multiple therapies.
Evidence level: Állatkísérletes. Állatmodellben vizsgálták.
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