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Abemaciclib + Aromatase Inhibitor
Abemaciclib inhibits CDK4/6 to block cell cycle progression in hormone receptor-positive breast cancer, while the aromatase inhibitor reduces estrogen production to further suppress tumor growth.
Abemaciclib inhibits CDK4/6 to block cell cycle progression in hormone receptor-positive breast cancer, while the aromatase inhibitor reduces estrogen production to further suppress tumor growth. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (first-line and subsequent lines of therapy).
At a glance
| Generic name | Abemaciclib + Aromatase Inhibitor |
|---|---|
| Also known as | Verzenios |
| Sponsor | Prof. Wolfgang Janni |
| Drug class | CDK4/6 inhibitor + Aromatase inhibitor combination |
| Target | CDK4/6 + Aromatase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Abemaciclib is a selective CDK4/6 inhibitor that prevents phosphorylation of the retinoblastoma protein, halting G1/S cell cycle transition in estrogen receptor-positive breast cancer cells. The combination with an aromatase inhibitor (which blocks estrogen synthesis) provides dual endocrine and cell cycle targeting, enhancing efficacy in hormone-dependent tumors. This combination is the basis of the marketed regimen for hormone receptor-positive, HER2-negative breast cancer.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (first-line and subsequent lines)
- Hormone receptor-positive, HER2-negative early breast cancer (adjuvant setting)
Common side effects
- Diarrhea
- Neutropenia
- Fatigue
- Nausea
- Abdominal pain
- Vomiting
- Anemia
- Arthralgia/myalgia
Key clinical trials
- A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PHASE1)
- A Study of LY4257496 in Participants With Cancer (OMNIRAY) (PHASE1)
- Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (PHASE1, PHASE2)
- Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
- A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence
- ALPINE: Maintenance Letrozole/Abemaciclib (PHASE2)
- Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases (PHASE1, PHASE2)
- A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Abemaciclib + Aromatase Inhibitor CI brief — competitive landscape report
- Abemaciclib + Aromatase Inhibitor updates RSS · CI watch RSS
- Prof. Wolfgang Janni portfolio CI