FDA Oncology Announcements

Anti-HER2 × Breast × Clear all

13 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 new interchangeable biosimilar to Perjeta

Drugs: Poherdy (pertuzumab-dpzb) · Anti-HER2 antibody, Perjeta (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 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 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 approves new formulation of Herceptin for subcutaneous use

Trial: SafeHER
Drug: Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) · Anti-HER2 antibody
Condition: Breast

FDA approves Herzuma as a biosimilar to Herceptin

Drugs: Herzuma (trastuzumab-pkrb) · Anti-HER2 antibody, Herceptin (trastuzumab) · 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 approves Ogivri as a biosimilar to Herceptin

Drugs: Ogivri (trastuzumab-dkst) · Anti-HER2 antibody, Herceptin (trastuzumab) · Anti-HER2 antibody
Conditions: BreastGastrointestinal

Pertuzumab Injection

Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane
Condition: Breast

FDA Approves Pertuzumab

Drugs: PERJETA (pertuzumab) · Anti-HER2 antibody, trastuzumab · Anti-HER2 antibody, docetaxel · Taxane
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