FDA has granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki), developed by Daiichi Sankyo, for treating adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have already undergone prior systemic treatment and lack satisfactory alternative options.
The decision was supported by data from a clinical trial program for Enhertu encompassing three multicenter trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02, offering hope for treating patients with IHC3+ solid tumors.
FDA excluded patients with ILD/pneumonitis history, active brain metastases, significant cardiac disease, or ECOG performance status >1 from Enhertu treatment.
The FDA highlighted collaborating with international regulatory agencies through Project Orbis to review Enhertu in treating IHC3+ solid tumors.
This review used Assessment Aid, a voluntary submission that can expedite Enhertu’s review process and bring hope to IHC3+ solid tumor patients.
Enhertu received Priority Review and Breakthrough Therapy Designation, programs designed to expedite promising treatments for IHC3+ solid tumors.
Healthcare professionals are urged to report any serious adverse events suspected to be linked to Enhertu use to the FDA’s MedWatch Reporting System.
Source: FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2
