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Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant — Treatment Landscape & Competitive Intelligence
Marketed treatment landscape
| Drug | Generic | Sponsor | Class | Target | Line of therapy | First approval |
|---|---|---|---|---|---|---|
| Palbociclib | palbociclib | Pfizer Inc. | CDK4/6 inhibitor | Cyclin-dependent kinases 4 and 6 (CDK4/6) |
Phase 3 pipeline
Phase 2 pipeline
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Sponsor landscape
- Pfizer Inc. · 1 drug in Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant
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Every new regulatory action, PDUFA date, or trial completion in Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant:
- Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant treatment updates — RSS
- Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant treatment updates — Atom
- Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant treatment updates — JSON
Cite this brief
Drug Landscape (2026). Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/treatment-of-adult-patients-with-endocrine-resistant-pik3ca-mutated-hr-positive-her2-negative-locally-advanced-or-metastatic-breast-cancer-as-detected-by-an-fda-approved-test-following-recurrence-on-or-after-completing-adjuvant-endocrine-therapy-in-combination-with-inavolisib-and-fulvestrant. Accessed 2026-06-10.
Related
- Treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy, in combination with inavolisib and fulvestrant full disease profile — treatment pathway, diagnostics, guidelines
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