RE:RE:How does Accelerated Approval work
Twenty-five patients were enrolled in BMS's Phase 1/2 KRYSTAL-1 study of adagrasib in non-small-cell lung cancer, colorectal cancer, and other solid tumors harboring the KRASG12C mutation and received at least one dose of adagrasib. 16 patients had NSCLC and 4 patients had colorectal cancer (CRC).
Adagrasib 600 mg twice a day was well tolerated and exhibited antitumor activity in patients with advanced solid tumors harboring the KRASG12C mutation.
The FDA's Accelerated Approval of KRAZATI with cetuximab in CRC appears to be based on the results of only 4 patients with colorectal cancer (CRC).
https://pubmed.ncbi.nlm.nih.gov/35167329/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9362872/