FDA approves new indication for Enhertu

The US Food and Drug Administration on Friday granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) 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.

Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC) discovered by Daiichi Sankyo (TYO: 4568) and being jointly developed and commercialized by the Japanese firm and UK pharma major AstraZeneca (LSE: AZN). Combined sales of the drug for the two companies amounted to $2.57 billion in 2023, more than doubling from $1.25 billion the year before.

The first tumor-agnostic approval of a HER2-directed therapy and ADC by the FDA was based on results from the subgroup of patients with HER2-positive IHC 3+ tumors in each of the DESTINY-PanTumor02,  DESTINY-Lung01 and  DESTINY-CRC02 Phase II trials. The FDA decision came ahead of the agency’s target date of May 30.