Sichuan Kelun-Biotech Secures First Global Approval for Sacituzumab Tirumotecan in Treating Advanced EGFR-Mutant NSCLC

Reuters
Jun 07
Sichuan Kelun-Biotech Secures First Global Approval for Sacituzumab Tirumotecan in Treating Advanced EGFR-Mutant NSCLC

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a leading biopharmaceutical company, has announced the approval of sacituzumab tirumotecan (sac-TMT) by the National Medical Products Administration (NMPA) for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This approval follows the progression on EGFR-tyrosine kinase inhibitor therapy and platinum-based chemotherapy. The approval, granted in March 2025, marks the first global sanctioning of a TROP2 antibody-drug conjugate for a lung cancer indication. The decision was based on encouraging data from the OptiTROP-Lung03 study, demonstrating significant survival benefits and a manageable safety profile of sac-TMT, which could potentially establish it as a new standard of care for this patient population.

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