Advancing toward Phase 2a evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track designation
Late-breaking data presented at WCLC highlight significant and sustained improvements in overall survival, including more than doubling five-year survival rates compared to chemotherapy alone
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
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