Last reviewed · How we verify

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

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 (disease) competitiv

1 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating 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, deduplicated by molecule. See the full disease page for line-of-therapy detail.

DrugGenericSponsorClassTargetLine of therapyFirst approval
Palbociclib palbociclib Pfizer Inc. CDK4/6 inhibitor Cyclin-dependent kinases 4 and 6 (CDK4/6)

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

  1. 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

Subscribe to ongoing alerts

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:

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

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing