Merck’s Sacituzumab Tirumotecan (Sac-TMT) Secures the US FDA’s Breakthrough Therapy Designation to Treat Non-Squamous NSCLC
Shots:
- The US FDA has granted BTD to sac-TMT (Kelun-Biotech holds the Greater China rights) for treating advanced or metastatic non-squamous EGFR-mutated (exon 19 deletion/exon 21 L858R) NSCLC in patients progressed post TKI & Pt-based CT
- Designation was supported by P-II expansion part of P-I/II study and two P-II trials of sac-TMT in EGFR-mutated NSCLC patients treated with at least two prior therapies, highlighted at ASCO 2023
- Merck is developing sac-TMT alone & combined with Keytruda under 10 global P-III trials for solid tumors, incl. TroFuse-004 (sac-TMT vs CT) & TroFuse-009 (sac-TMT vs doublet CT) in previously treated EGFR-mutated NSCLC
Ref: Merck | Image: Merck
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
