Does anything think accelerated approval is a pipe
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Posted On: 05/04/2025 10:53:10 AM
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.
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