Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC) in patients who have not responded to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) and platinum-based chemotherapy.
SKB264 is a TROP2-targeted antibody-drug conjugate (ADC) and was the subject of a licensing agreement with Merck, Sharp & Dohme (MSD) for markets outside Greater China in May 2022. Phase II clinical trials have demonstrated a remarkable 100% disease control rate (DCR) among EGFR mutant patients with locally advanced or metastatic NSCLC receiving sacituzumab tirumotecan at a dosage of 5 mg/kg every two weeks. The drug has previously received both priority review and Breakthrough Therapy Designation (BTD) from the CDE for its use in treating triple-negative breast cancer.- Flcube.com
