FDA Oncology Announcements

PI3K alpha inhibitor × Clear all

3 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 alpelisib for PIK3CA-related overgrowth spectrum

Trial: EPIK-P1
Drug: Vijoice (alpelisib) · PI3K alpha inhibitor
Condition: Other

FDA approves alpelisib for metastatic breast cancer

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