Merck announced on December 3, 2024, that the U.S. FDA granted Breakthrough Therapy designation to sacituzumab tirumotecan. This investigational trophoblast cell-surface antigen 2-directed antibody drug conjugate is for patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor mutations.
The designation applies to patients whose disease progressed on or after tyrosine kinase inhibitor and platinum-based chemotherapy. Sacituzumab tirumotecan is being developed in collaboration with Kelun-Biotech.
Breakthrough Therapy designation is granted to expedite the development and review of drugs for serious or life-threatening conditions. This accelerates the potential availability of a new treatment option for a challenging lung cancer population, highlighting the promise of Merck's oncology pipeline.
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