Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination
Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population
In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial
KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival
Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
Longest survival follow-up ever reported for immunotherapy treatment in this setting
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
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