Merck Receives FDA Breakthrough Therapy Designation for Investigational Lung Cancer Treatment

Merck is advancing the global development of sac-TMT through multiple ongoing Phase 3 trials.

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Dec 03, 2024
Summary
  • The Breakthrough Therapy designation accelerates medication research and evaluation for life-threatening illnesses.
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Merck (MRK, Financials) stated that sacituzumab tirumotecan (sac-TMT) was designated a Breakthrough Therapy by the FDA for advanced or metastatic nonsquamous non-small cell lung cancer with epidermal growth factor receptor mutations. The stock rose 1.7% after this announcement.

Patients who had their malignancy worsen following tyrosine kinase inhibitor and platinum-based chemotherapy are favorable candidates.

Sac-TMT is a novel antibody-drug combination being evaluated. It targets TROP2, a transmembrane glycoprotein overexpressed in several epithelial malignancies, including NSCLC. Sac-TMT protects healthy organs by targeting cancer cells that generate TROP2 with a deadly payload. Makes treatment more effective.

Merck & Co. and Kelun-Biotech developed sac-TMT, which has showed promise in human research. Based on findings from the Phase 3 OptiTROP-Breast01 research, the medication has already gained initial marketing approval in China for treating advanced or metastatic triple-negative breast cancer, according to Merck.

The FDA's Breakthrough Therapy title accelerates medicine development for deadly diseases. This categorization for sac-TMT highlights its potential as a significant treatment advance for EGFR-mutated NSCLC.

Cancer treatment is increasingly using ADCs, which combine chemotherapy with customized treatment. Sac-TMT follows this trend. This strategy aims to improve outcomes for hard-to-treat tumors including NSCLC with EGFR mutations.

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