FDA Oncology Announcements

Anti-HER2 × Breast × Clear all

5 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 margetuximab for metastatic HER2-positive breast cancer

Trial: SOPHIA
Drug: MARGENZA (margetuximab-cmkb) · Anti-HER2 antibody
Condition: Breast

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

Trial: FeDeriCa
Drug: PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) · Anti-HER2 antibody
Condition: Breast

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer

Trial: APHINITY
Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody
Condition: Breast

FDA Expands the Use of Trastuzumab (Herceptin) for Early Stage Breast Cancer After Primary Therapy

Drug: Herceptin (trastuzumab) · Anti-HER2 antibody
Condition: Breast