FDA Oncology Announcements

Estrogen receptor inhibitor × Breast × Clear all

7 Announcements

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 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 capivasertib with fulvestrant for breast cancer

Trial: CAPItello-291
Drugs: Truqap (capivasertib) · AKT1 inhibitor, fulvestrant · Estrogen receptor inhibitor
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 alpelisib for metastatic breast cancer

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

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

Palbociclib (IBRANCE Capsules)

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