FDA Grants Accelerated Approval for HER2+ Cancer Treatment
On April 5, 2024, the US Food and Drug Administration (FDA) announced the accelerated approval of fam-trastuzumab deruxtecan-nxki (Enhertu®) to treat patients with unresectable or metastatic HER2-positive solid tumors. This treatment is part of a growing trend of tissue-agnostic drugs -- treatments that are prescribed based on the biomarkers found in the tumor rather than the organ where the cancer originated. It is available to patients through the FDA’s accelerated approval process, which hurries exciting treatments to patients who need them. Accelerated approvals can be controversial
