FDA Oncology Announcements

Breast × Clear all

44 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 imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Trial: EMBER-3
Drug: Inluriyo (imlunestrant) · Estrogen receptor inhibitor
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 approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer

Drug: Datroway (datopotamab deruxtecan-dlnk) · Anti-TROP2 antibody-drug conjugate
Condition: Breast

FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer

Trial: INAVO120
Drugs: Itovebi (inavolisib) · PI3K alpha inhibitor, palbociclib · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer

Trial: NATALEE
Drug: Kisqali (ribociclib) · CDK inhibitor
Condition: Breast

FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

Trial: TRIDENT-1
Drug: AUGTYRO (repotrectinib) · ROS1 inhibitor
Condition: Other solid neoplasm

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 approves capivasertib with fulvestrant for breast cancer

Trial: CAPItello-291
Drugs: Truqap (capivasertib) · AKT1 inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

FDA expands early breast cancer indication for abemaciclib with endocrine therapy

Trial: monarchE
Drug: Verzenio (abemaciclib) · CDK inhibitor
Condition: Breast

FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer

Trial: TROPiCS-02
Drug: Trodelvy (sacituzumab govitecan-hziy) · Anti-TACSTD2 antibody-drug conjugate
Condition: Breast

FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Trial: EMERALD
Drug: Orserdu (elacestrant) · Estrogen receptor inhibitor
Condition: Breast

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Other solid neoplasm

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

Trial: SIOPEL6
Drug: Pedmark (sodium thiosulfate)
Condition: Other solid neoplasm

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 accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: Other solid neoplasm

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 olaparib for adjuvant treatment of high-risk early breast cancer

Trial: OlympiA
Drug: Lynparza (olaparib) · PARP inhibitor
Condition: Breast

FDA approves abemaciclib with endocrine therapy for early breast cancer

Drug: Verzenio (abemaciclib) · CDK inhibitor
Condition: Breast

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer

Trial: MK-3475-522
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Breast

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

Trial: ASCENT
Drug: Trodelvy (sacituzumab govitecan) · Anti-TACSTD2 antibody-drug conjugate
Condition: Breast

FDA approves margetuximab for metastatic HER2-positive breast cancer

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

FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer

Trial: KEYNOTE-355
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Breast

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

FDA issues alert about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer

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 pembrolizumab for adults and children with TMB-H solid tumors

Trial: KEYNOTE 158
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

Drug: TRODELVY (sacituzumab govitecan-hziy) · Anti-TACSTD2 antibody-drug conjugate
Condition: Breast

FDA approves tucatinib for patients with HER2-positive metastatic breast cancer

Trial: HER2CLIMB
Drug: TUKYSA (tucatinib) · ERBB2 inhibitor
Condition: Breast

FDA approves neratinib for metastatic HER2-positive breast cancer

Trial: NALA
Drugs: NERLYNX (neratinib) · ERBB2 inhibitor, capecitabine · Fluoropyrimidine
Condition: Breast

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 alpelisib for metastatic breast cancer

Trial: SOLAR-1
Drugs: PIQRAY (alpelisib) · PI3K alpha inhibitor, fulvestrant · Estrogen receptor inhibitor
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 atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer

Drugs: TECENTRIQ (atezolizumab) · Anti-PD-L1 antibody, paclitaxel protein-bound · Taxane
Condition: Breast

FDA approves larotrectinib for solid tumors with NTRK gene fusions

Drug: VITRAKVI (larotrectinib) · TRK inhibitor
Condition: Other solid neoplasm

FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer

Trial: EMBRACA
Drug: TALZENNA (talazoparib) · PARP inhibitor
Condition: Breast

FDA expands ribociclib indication in HR-positive, HER2-negative advanced or metastatic breast cancer

Trials: MONALEESA-7, MONALEESA-3
Drug: Kisqali (ribociclib) · CDK inhibitor
Condition: Breast

FDA approves abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer

Drug: VERZENIO (abemaciclib) · CDK inhibitor
Condition: Breast

FDA approves olaparib for germline BRCA-mutated metastatic breast cancer

Trial: OlympiAD
Drug: Lynparza (olaparib) · PARP inhibitor
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 abemaciclib for HR-positive, HER2-negative breast cancer

Drugs: VERZENIO (abemaciclib) · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

FDA approves neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer

Trial: ExteNET
Drug: NERLYNX (neratinib) · ERBB2 inhibitor
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