Neoplasm.News

Breast × Clear all

47 Announcements

2026-05-22

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer

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

2026-05-15

FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer

Trial: DESTINY-Breast05
Drug: T-DXd (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Breast

2026-05-01

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

Trial: VERITAC-2
Drug: Veppanu (vepdegestrant) · Proteolysis-targeting chimera estrogen receptor degrader
Condition: Breast

2025-12-15

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

2025-09-25

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

2025-01-27

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

2025-01-17

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

2024-10-10

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

2024-09-17

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

2024-06-13

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

2024-04-05

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

2023-11-16

FDA approves capivasertib with fulvestrant for breast cancer

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

2023-03-03

FDA expands early breast cancer indication for abemaciclib with endocrine therapy

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

2023-02-03

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

2023-01-27

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

2022-09-21

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

Trial: LIBRETTO-001
Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Other solid neoplasm

2022-09-20

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

Trial: SIOPEL6
Condition: Other solid neoplasm

2022-08-05

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

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

2022-06-22

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, trametinib is not indicated · MEK inhibitor
Condition: Other solid neoplasm

2022-05-04