The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.
The FDA on Thursday pushed back its target action dates for Amgen’s Lumakras and Intercept Pharmaceuticals’ Ocaliva, for which the respective companies are seeking full approval.
Lumakras and Ocaliva are approved under the FDA’s accelerated pathway. Both therapies have also shown mixed confirmatory data and have failed to secure the backing of external experts in their respective advisory committee meetings.
Intercept did not provide a reason for the delay, only announcing in its press release that the regulator will need to continue its review of the supplemental New Drug Application. Ocaliva’s original target action date was supposed to be on Oct. 15. The FDA has yet to provide a new deadline for its decision. Intercept is seeking full approval for Ocaliva for primary biliary cholangitis (PBC).
Vivek Devaraj, U.S. President at Intercept, said that the pharma will “continue to engage with the FDA regarding our pending application.”
Last month, the FDA’s Gastrointestinal Drug Advisory Committee nearly unanimously recommended against Ocaliva, arguing that Intercept had not provided enough data to support the drug’s clinical benefit. Only one panelist voted in favor of Ocaliva. The vote was also overwhelmingly against Intercept in terms of Ocaliva’s benefit-risk profile as a second-line treatment for PBC.
Prior to the meeting, the FDA in a briefing document flagged issues with Ocaliva’s confirmatory data, which “failed to demonstrate efficacy.” The regulator also pointed to “unfavorable trends” in liver transplantation and mortality in patients on Ocaliva.
Designed to be orally taken, Ocaliva is a farsenoid X receptor agonist that prevents the toxic accumulation of bile acid in the liver. The drug won the FDA’s accelerated approval for PBC in 2016.
Meanwhile, the FDA’s delay for Amgen, which was first reported by Endpoints News, covers the drug application for using the drug in metastatic colorectal cancer.
The move comes after disappointing survival data from the Phase III CodeBreaK 300 study, which looked at the combination of Lumakras in combination with Vectibix. The Vectibix combo cut the risk of death by 17% to 30% versus an investigator’s choice of intervention—though these estimates fell short of statistical significance.
As in the case of Intercept, the FDA has not yet indicated when it expects to provide a decision.
Lumakras won the FDA’s accelerated approval in June 2021 for non-small cell lung cancer patients harboring the KRAS G12C mutation. In December 2023, however, the FDA declined to grant Lumakras full approval in this indication, following a negative advisory committee vote.
