Lumakras Faces Setback in Bid for Full FDA Approval Amid ODAC Scrutiny Over CodeBreaK 200 Data

Recently (October 5, 2023), the FDA held an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss whether Amgen's KRAS G12C inhibitor Lumakras (sotorasib) could be converted from accelerated approval to full approval. The committee voted on the reliability of the PFS data from the confirmatory clinical trial CodeBreaK 200, which serves as the basis for the potential full approval. Currently, it appears that the expert panel has significant doubts about Lumakras. InventisBio’s oral KRAS G12C inhibitor D-1553 is the first China-produced KRAS inhibitor to publish clinical data.