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Phase 3

Development Phase

1

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

Upcoming Catalysts
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Nov '26
RHHBYPhase 3

Inavolisib Phase 3 Est. Readout

Inavolisib
Nov 2026~STALE
CT.gov
00%
Drug Information

Target Indication

Breast Cancer

Clinical Trial

NCT05646862

Last updated: 1/13/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA7/18/2025

Itovebi

Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment (see section 5.1). Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist.

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