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

The U.S. Food and Drug Administration (FDA) staff reviewers have raised concerns about the effectiveness of Amgen’s lung cancer drug, Lumakras, based on the company’s late-stage confirmatory study. The FDA panel of expert advisers will convene on Thursday to evaluate the reliability of the data provided by Amgen.

Lumakras was initially approved by the FDA in 2021 under an accelerated pathway for advanced lung cancer patients with KRAS mutations. The confirmatory study was a requirement for the drug’s accelerated approval. However, FDA staff reviewers have highlighted several issues with the study, including high censorship and the absence of patient follow-up with those who withdrew consent.

According to briefing documents published on the FDA’s website, the late-stage trial conducted by Amgen may not be considered “adequate and well-controlled.” The extent of benefit provided by Lumakras compared to chemotherapy may have been impacted by these issues. The data from the confirmatory study showed a 34% reduction in the risk of disease progression in advanced lung cancer patients compared to chemotherapy in a clinical trial. However, there was no significant difference in overall survival between the two treatments.

Amgen’s drug targets a mutated form of the KRAS gene, which is present in about 13% of non-small cell lung cancers and some other solid tumors. Lumakras generated $285 million in sales in 2022.

While the FDA usually follows the advice of its expert panel, it is not bound to do so. The agency is expected to make a decision on the drug by December 24. Amgen’s shares fell nearly 1.3% to $262.92 in early trading following the news.

Amgen will have an opportunity to address the concerns raised by the FDA staff during the panel meeting. The company remains committed to providing effective treatments for patients with advanced lung cancer and will work closely with the FDA to address any issues and ensure the safety and efficacy of Lumakras.