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Abemaciclib + Fulvestrant
Abemaciclib inhibits CDK4/6 to block cell cycle progression, while fulvestrant is an estrogen receptor antagonist that degrades the ER protein, together blocking hormone-driven breast cancer growth.
Abemaciclib inhibits CDK4/6 to block cell cycle progression, while fulvestrant is an estrogen receptor antagonist that degrades the ER protein, together blocking hormone-driven breast cancer growth. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women, Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women (with endocrine therapy).
At a glance
| Generic name | Abemaciclib + Fulvestrant |
|---|---|
| Also known as | Verzenios |
| Sponsor | Prof. Wolfgang Janni |
| Drug class | CDK4/6 inhibitor + estrogen receptor antagonist |
| Target | CDK4/6 and estrogen receptor (ER) |
| 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 hormone receptor-positive breast cancer cells. Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and promotes degradation of the estrogen receptor, eliminating ER-mediated signaling. The combination provides dual blockade of cell cycle and estrogen signaling pathways.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in premenopausal women (with endocrine therapy)
Common side effects
- Neutropenia
- Leukopenia
- Diarrhea
- Fatigue
- Nausea
- Abdominal pain
- Vomiting
- Anemia
- Infection
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)
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (PHASE3)
- 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)
- Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer (PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (PHASE1, PHASE2)
- Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (PHASE3)
- Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) (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 + Fulvestrant CI brief — competitive landscape report
- Abemaciclib + Fulvestrant updates RSS · CI watch RSS
- Prof. Wolfgang Janni portfolio CI