FDA has approved Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
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...
