AstraZeneca's Imfinzi Gets the US FDA Priority Review and BTD for LS-SCLC
Shots:
- Based on P-III (ADRIATIC) study data, AstraZeneca filled sBLA for Imfinzi and received the Priority Review and BTD in the US for LS-SCLC; regulatory decision is anticipated in Q4’24
- The study showed 27% reduction in death risk in Imfinzi participants vs. PBO; mOS was 55.9mos. vs. 33.4mos and 57% vs 48% of participants were alive at 3yrs.
- 24% reduction in disease progression/death was observed in Imfinzi participants vs. PBO; mPFS was 16.6mos. vs. 9.2mos.; 46% vs. 34% of participants had not experienced disease progression at 2yrs., safety profile was manageable & consistent
Ref: AstraZeneca | Image: AstraZeneca
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