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Posted On: 05/04/2025 10:53:10 AM
Post# of 155783
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 / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com
Federal Whistleblower / Special Operations Tactical Unit
USAF: Phoenix Raven #2143
HHS & SEC Whistleblower: HL-1412396
DOJ Investigation Report/ Whistleblower ID: 20250705-0001
NIH Case Reference: CS1137565
Founder & CEO of FireGate Bioscience
USPTO: Lead Inventor of the HIV Cure & AI Federal Oversight Program
⸻
Public Links
FireGate Bioscience: https://www.firegatebioscience.com
NotYourDrug.com: https://www.notyourdrug.com