FDA Oncology Announcements

Anti-HER2 ADC × Clear all

10 Announcements

FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer

Drugs: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate, pertuzumab · Anti-HER2 antibody
Condition: Breast

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer

Trial: DB-06
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

Trials: DPT02, DESTINY-Lung01, DESTINY-CRC02
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Other solid neoplasm

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

Trial: DESTINY-LUNG02
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Thoracic

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-low breast cancer

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA grants regular approval to fam-trastuzumab deruxtecan-nxki for breast cancer

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Gastrointestinal

FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer

Trial: DESTINY-Breast01
Drug: ENHERTU (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA approves ado-trastuzumab emtansine for early breast cancer

Drug: KADCYLA (ado-trastuzumab emtansine) · Anti-HER2 antibody-drug conjugate
Condition: Breast

FDA Approves Ado-Trastuzumab Emtansine

Drug: KADCYLA (ado-trastuzumab emtansine) · Anti-HER2 antibody-drug conjugate
Condition: Breast