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Posted On: 05/04/2025 10:53:10 AM
Post# of 157455
Does anything think accelerated approval is a pipe dream or within reach? Been digging into it.
Examples:
• Sotorasib (Lumakras): Data for sotorasib, targeting KRAS G12C mutations in non-small cell lung cancer, were presented at ESMO. Subsequently, the FDA granted Accelerated Approval on May 28, 2021. 
• Pembrolizumab (Keytruda): Clinical trial data supporting pembrolizumab’s Accelerated Approval for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors were presented at ESMO. The FDA granted Accelerated Approval in May 2017.
ESMO presentations often come right before or around Accelerated Approval timing.
Examples:
• Sotorasib (Lumakras): Data for sotorasib, targeting KRAS G12C mutations in non-small cell lung cancer, were presented at ESMO. Subsequently, the FDA granted Accelerated Approval on May 28, 2021. 
• Pembrolizumab (Keytruda): Clinical trial data supporting pembrolizumab’s Accelerated Approval for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors were presented at ESMO. The FDA granted Accelerated Approval in May 2017.
ESMO presentations often come right before or around Accelerated Approval timing.


Daniel Rizzo
Federal Whistleblower
Case References
• HHS & SEC Whistleblower: HL-1412396
• DOJ Investigation Report / Whistleblower ID: 20250705-0001
• NIH Case Reference: CS1137565
• DoD Case: 16282
• IC IG / 50 U.S.C. §3033 / ARPA-H (Advanced Research Projects Agency for Health)
Founder & CEO
FireGate BioTech | AI Lux Veritas™
Contact FireGate Biotech
https://img1.wsimg.com/blobby/go/05a949a0-169...5_FULL.pdf
Federal Whistleblower
Case References
• HHS & SEC Whistleblower: HL-1412396
• DOJ Investigation Report / Whistleblower ID: 20250705-0001
• NIH Case Reference: CS1137565
• DoD Case: 16282
• IC IG / 50 U.S.C. §3033 / ARPA-H (Advanced Research Projects Agency for Health)
Founder & CEO
FireGate BioTech | AI Lux Veritas™
Contact FireGate Biotech
https://img1.wsimg.com/blobby/go/05a949a0-169...5_FULL.pdf