Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer
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- The US FDA has granted accelerated approval to Amgen’s Imdelltra (DLL3-targeting bispecific T-cell engager) for treating extensive-stage small cell lung cancer (ES-SCLC) adults whose disease progressed post Pt-based CT. Full approval depends upon confirmatory trials
- The approval was based on the P-II (DeLLphi-301) study assessing Imdelltra (10mg, Q2W) in SCLC patients (n=99) failing on 2 or more previous lines of treatment & administered with the 10mg Q2W dosing regimen
- The results depicted an ORR of 40%, mDoR of 9.7mos. and mOS of 14.3mos. Further evaluation continues for complete survival data
Ref: Amgen | Image: Amgen
Related News:- The US FDA Accepts Amgen's BLA for Tarlatamab and Granted Priority Review for Advanced Small Cell Lung Cancer
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
