FDA Staff Reviewers Express Concerns Over Amgen’s Lung Cancer Drug Study

The U.S. Food and Drug Administration (FDA) staff reviewers have raised doubts about the sufficiency of Amgen’s late-stage study to confirm the effectiveness of its lung cancer drug, Lumakras. The FDA’s expert advisers will convene on Thursday to vote on the reliability of the data. Lumakras, which targets a mutated form of the KRAS gene found in about 13% of non-small cell lung cancers, received accelerated approval in 2021 for advanced lung cancer patients with KRAS mutations.

The FDA grants accelerated approval based on promising data but requires confirmatory trials for traditional approval. According to briefing documents published on the FDA’s website, the staff reviewers have identified several issues with the way Amgen’s late-stage confirmatory study was conducted, suggesting it may not be considered “adequate and well-controlled.” Analysts speculate that the FDA panel could recommend an additional late-stage trial.

Despite the concerns raised, analysts believe that the negative assessment does not imply Lumakras will be pulled from the market. William Blair analyst Matt Phipps remarked that while the documents may appear negative for Amgen, Lumakras’ market presence is unlikely to be affected. In a clinical trial, Lumakras demonstrated a 34% reduction in the risk of disease progression compared to chemotherapy.

The FDA typically follows the advice of its panel but is not obligated to do so. A decision on traditional approval for Lumakras is expected by December 24. Amgen’s shares declined nearly 2% following the news.

As the FDA’s panel meeting approaches, stakeholders will be closely monitoring the outcome, which will have implications for the future availability of Lumakras as a treatment option for patients with advanced lung cancer.