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 because there is less scientific rigor required and the overall effectiveness of the treatments is still being studied.
For more details, including common side effects, please see the FDA press release.
You can find additional information about this FDA approval in the newsfeed on this website.