FDA Delays Decision on Full Approval for Amgen’s Lumakras and Intercept’s Ocaliva

Delay in Decision Dates:
The FDA has pushed back its target action dates for deciding on full approval for Amgen's Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals' Ocaliva for primary biliary cholangitis.

Reasons for Delay:
The delays come after both drugs showed mixed confirmatory data and failed to secure the backing of external experts in their respective advisory committee meetings. For Ocaliva, the FDA flagged issues with its confirmatory data, which failed to demonstrate efficacy and showed unfavorable trends in liver transplantation and mortality.

Current Status:
Both Lumakras and Ocaliva are currently approved under the FDA's accelerated pathway. The FDA has not yet provided new deadlines for its decisions on full approval.

Previous Developments:
The FDA's Gastrointestinal Drug Advisory Committee recommended against Ocaliva, citing insufficient data to support its clinical benefit. Similarly, Amgen's Lumakras faced disappointing survival data from the Phase III CodeBreaK 300 study, which did not meet statistical significance.

Impact:
The delays indicate that the FDA is taking a cautious approach to granting full approval, emphasizing the need for robust and convincing data to support the drugs' efficacy and safety.