FDA Advisers Question Reliability of Data for Amgen’s Lumakras in Advanced Lung Cancer Treatment

Advisers to the U.S. Food and Drug Administration (FDA) have raised concerns about the reliability of data from a late-stage trial for Amgen’s Lumakras in the treatment of advanced lung cancer. The drug, which was granted accelerated approval in 2021, requires confirmatory data for traditional approval. The FDA panel, in line with the assessment of FDA staff reviewers, voted 10 to 2 that the main goal of the confirmatory study could not be relied upon to assess the benefits of Lumakras.

The FDA panel and staff reviewers identified several issues with the trial, including potential bias and insufficient data to confirm the drug’s benefits. Concerns were also raised about the study’s methodology and the loss of follow-up data from patients who withdrew consent. Lumakras is currently approved for patients with advanced lung cancer and mutations of the KRAS gene, whose disease has worsened after prior treatments.

While the FDA generally follows the advice of its expert panels, it is not bound to do so. The agency is expected to make a decision on the traditional approval of Lumakras by December 24th. Amgen will likely work closely with the FDA to address the concerns raised and provide additional data to support the drug’s efficacy.

The development of innovative treatments for advanced lung cancer is crucial in improving patient outcomes. Amgen’s Lumakras has shown promise in targeting specific gene mutations associated with this type of cancer. The FDA’s thorough evaluation process ensures that drugs meet the highest standards of safety and efficacy before being made available to patients.

Amgen, a leading biotechnology company, remains committed to advancing scientific research and delivering innovative therapies to patients in need. The outcome of the FDA’s decision will shape the future of Lumakras as a potential treatment option for patients with advanced lung cancer.