The FDA Oncologic Drugs Advisory Committee concurred with the FDA staff that the Amgen Inc. confirmatory trial of the lung cancer therapy sotorasib (Lumakras) was uninterpretable as a result of a perceived loss of equipoise.
By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it. To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...
As a radiation oncologist, I am struck by how often the decisive variable in lung cancer is not the sophistication of our therapy, but the timing of our encounter with the disease. The American Cancer Society projects 618,120 cancer deaths in the United States in 2025, with lung cancer remaining as the single largest contributor,...
