The FDA on April 5, 2024, granted accelerated approval to Fam-trastuzumab deruxtecan-nxki (ENHERTU®) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
This is the 6th Tumor-Agnostic therapeutic target for which an agent has received regulatory agency approval.
A current summary of the Tumor-Agnostic therapeutic targets, and agents approved, is provided below. Please review the drug Prescribing Information for the respective therapeutic agents, as NOT all products are approved for First Line therapy.
MMRd/MSI-H: Pembrolizumab (KEYTRUDA®) and Dostarlimab (JEMPERLI®)
TMB-H: Pembrolizumab (KEYTRUDA®)
NTRK fusions: Larotrectinib (VITRAKVI) and Entrectinib (ROZLYTREK®)
BRAF V600E: Dabrafenib (TAFINLAR®) plus Trametinib (MEKINIST®)
RET Fusions: Selpercatinib (RETEVMO®)
HER2 Overexpression: Fam-trastuzumab deruxtecan (ENHERTU®)
The National Cancer Institute describes Tumor-Agnostic therapy as a type of targeted treatment that uses drugs or other substances to treat cancer based on the cancer’s genetic and molecular features, without regard to the cancer type or where the cancer started in the body. Tissue-Agnostic therapy uses the same drug to treat all cancer types that have the genetic mutation or biomarker, that is targeted by the drug.
