Shots:
- 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 | Press Release
Related News:- Azurity Pharmaceuticals’ Myhibbin (Mycophenolate Mofetil) Receives the US FDA’s Approval to Treat Organ Rejection
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
