FDA Oncology Announcements

CDK inhibitor × Breast × Clear all

7 Announcements

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 expands early breast cancer indication for abemaciclib with endocrine therapy

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

FDA approves abemaciclib with endocrine therapy for early breast cancer

Drug: Verzenio (abemaciclib) · CDK 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 abemaciclib for HR-positive, HER2-negative breast cancer

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