FDA Oncology Announcements

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79 Announcements

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

2025-11-13

FDA approves new interchangeable biosimilar to Perjeta

Drugs: Poherdy (pertuzumab-dpzb) · Anti-HER2 antibody, Perjeta (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

2025-09-19

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

Trial: MK-3475A-D77
Drug: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody
Condition: Other solid neoplasm

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

Drug: Kisqali (ribociclib) · CDK 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

2023-10-20

FDA expands pediatric indication for entrectinib and approves new pellet formulation

Trial: STARTRK-NG
Drug: Rozlytrek (entrectinib) · TRK inhibitor
Condition: Other solid neoplasm

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

2022-12-14

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

Conditions: BreastGastrointestinal

2022-09-21

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

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

2022-05-04

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

2022-03-11

FDA approves olaparib for adjuvant treatment of high-risk early breast cancer

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

2021-10-12

FDA approves abemaciclib with endocrine therapy for early breast cancer

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

2021-08-18

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

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

2021-07-26

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

2021-04-07

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

2020-12-16

FDA approves margetuximab for metastatic HER2-positive breast cancer

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

2020-12-16

FDA approves margetuximab for metastatic HER2-positive breast cancer

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

2020-11-13

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

2020-11-13

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

2020-10-26

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

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

2020-10-26

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

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

2020-10-26

FDA approves liquid biopsy NGS companion diagnostic test for multiple cancers and biomarkers

Conditions: BreastGynecologicThoracic

2020-09-08

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

Condition: Breast

2020-09-08

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

Condition: Breast

2020-06-29

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

2020-06-29

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

2020-06-16

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

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

2020-06-16

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

2020-04-22

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

2020-04-22

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

2020-04-17

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

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

2020-04-17

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

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

2020-02-25

FDA approves neratinib for metastatic HER2-positive breast cancer

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

2020-02-25

FDA approves neratinib for metastatic HER2-positive breast cancer

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

2019-12-20

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

2019-05-24

FDA approves alpelisib for metastatic breast cancer

Trial: SOLAR-1
Drugs: PIQRAY (alpelisib) · PI3K alpha inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

2019-05-03

FDA approves ado-trastuzumab emtansine for early breast cancer

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

2019-03-08

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

2019-02-28

FDA approves new formulation of Herceptin for subcutaneous use

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

2018-12-14

FDA approves Herzuma as a biosimilar to Herceptin

Drugs: Herzuma (trastuzumab-pkrb) · Anti-HER2 antibody, Herceptin (trastuzumab) · Anti-HER2 antibody
Condition: Breast

2018-11-26

FDA approves larotrectinib for solid tumors with NTRK gene fusions

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

2018-10-16

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

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

2018-07-18

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

2018-02-26

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

Trial: MONARCH 3
Drug: VERZENIO (abemaciclib) · CDK inhibitor
Condition: Breast

2018-01-12

FDA approves olaparib for germline BRCA-mutated metastatic breast cancer

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

2017-12-20

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

2017-12-01

FDA approves Ogivri as a biosimilar to Herceptin

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

2017-11-30

FDA grants marketing approval to FoundationOne CDx in vitro diagnostic

Conditions: BreastDermatologicGastrointestinalGynecologicThoracic

2017-09-28

FDA approves abemaciclib for HR-positive, HER2-negative breast cancer

Trials: MONARCH 1, MONARCH 2
Drugs: VERZENIO (abemaciclib) · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

2017-07-17

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

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

2016-02-19

Palbociclib (IBRANCE Capsules)

Drugs: IBRANCE Capsules (palbociclib) · CDK inhibitor, fulvestrant · Estrogen receptor inhibitor
Condition: Breast

2015-02-03

Palbociclib

Drugs: IBRANCE (palbociclib) · CDK inhibitor, letrozole · Aromatase inhibitor third generation
Condition: Breast

2014-11-14

Bevacizumab solution in combination with Paclitaxel

Drugs: Avastin (bevacizumab solution for intravenous infusion) · Anti-VEGFR antibody, Avastin (intravenous infusion) , paclitaxel · Taxane
Condition: Breast

2013-09-30

Pertuzumab Injection

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

2013-02-22

FDA Approves Ado-Trastuzumab Emtansine

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

2012-07-20

Everolimus 2012

Drugs: Afinitor (everolimus) · MTOR inhibitor, exemestane · Aromatase inhibitor third generation
Condition: Breast

2012-06-08

FDA Approves Pertuzumab

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

2012-04-26

Everolimus (2012)

Drug: Afinitor tablets (everolimus) · MTOR inhibitor
Condition: Breast

2011-09-16

Denosumab (Prolia)

Drug: Prolia (denosumab) · Anti-RANKL antibody
Conditions: BreastGenitourinary

2010-11-15

Eribulin Mesylate

Drug: Halaven (eribulin mesylate) · Non-taxane microtubule dynamics inhibitor
Condition: Breast

2010-11-01

Trastuzumab - (Labeling Change)

Conditions: BreastGastrointestinal

2010-01-29

Tykerb

Drug: Tykerb (lapatinib) · ERBB2 inhibitor
Condition: Breast

2008-02-22

Bevacizumab Granted Accelerated Approval

Drugs: Avastin (bevacizumab) · Anti-VEGFR antibody, paclitaxel · Taxane
Condition: Breast

2007-10-16

Ixabepilone

Drugs: Ixempra (ixabepilone) · Non-taxane microtubule dynamics inhibitor, Ixempra (injection)
Condition: Breast

2007-09-13

Raloxifene hydrochloride

Drug: EVISTA (raloxifene hydrochloride) · Selective estrogen receptor modulator
Condition: Breast

2007-03-13

Lapatinib

Condition: Breast

2006-11-16

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

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