Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme (MSD, NYSE: MRK) and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has been granted a breakthrough therapy designation (BTD) by the US FDA. This designation is for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations, specifically exon 19 deletion or exon 21 L858R, who have experienced disease progression on or after treatment with tyrosine kinase inhibitors (TKI) and platinum-based chemotherapy.
Licensing Deal and Global Reach
In May 2022, MSD secured a licensing deal for sacituzumab tirumotecan for territories outside Greater China, expanding the drug’s potential global reach. The BTD award by the FDA is based on compelling data from a Phase I/II study, which demonstrated significant improvements in patient survival outcomes for EGFR mutant NSCLC patients who had undergone at least second-line treatment.
China’s BTD Status and Treatment Landscape
In China, sacituzumab tirumotecan had already earned a BTD status in January of the previous year for the treatment of locally advanced or metastatic EGFR mutant NSCLC adult patients who have failed EGFR-TKI treatment. This recognition in China, coupled with the US FDA’s BTD, underscores the drug’s potential to address a significant unmet medical need in the treatment of EGFR mutated NSCLC.-Fineline Info & Tech
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