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Endocrine therapy + Abemaciclib
Endocrine therapy + Abemaciclib is a CDK4/6 inhibitor + endocrine therapy combination Small molecule drug developed by Japanese Foundation for Cancer Research. It is currently in Phase 3 development for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (in combination with endocrine therapy).
Endocrine therapy combined with abemaciclib (a CDK4/6 inhibitor) blocks estrogen signaling and cell-cycle progression to inhibit hormone receptor-positive breast cancer growth.
Endocrine therapy combined with abemaciclib (a CDK4/6 inhibitor) blocks estrogen signaling and cell-cycle progression to inhibit hormone receptor-positive breast cancer growth. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (in combination with endocrine therapy).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Endocrine therapy + Abemaciclib |
|---|---|
| Sponsor | Japanese Foundation for Cancer Research |
| Drug class | CDK4/6 inhibitor + endocrine therapy combination |
| Target | CDK4/6 (abemaciclib component); estrogen receptor (endocrine therapy component) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Endocrine therapy (such as aromatase inhibitors, tamoxifen, or fulvestrant) suppresses estrogen production or blocks estrogen receptor signaling in hormone receptor-positive breast cancer. Abemaciclib inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), which are critical for G1/S cell-cycle transition. The combination overcomes endocrine resistance by simultaneously targeting hormone signaling and cell-cycle checkpoints.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (in combination with endocrine therapy)
Common side effects
- Neutropenia
- Diarrhea
- Fatigue
- Nausea
- Abdominal pain
- Infection
- Anemia
Key clinical trials
- Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer (PHASE4)
- Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt (PHASE4)
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (PHASE3)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (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)
- A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) (PHASE3)
- Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
- Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib (PHASE2)
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:
- Endocrine therapy + Abemaciclib CI brief — competitive landscape report
- Endocrine therapy + Abemaciclib updates RSS · CI watch RSS
- Japanese Foundation for Cancer Research portfolio CI
Frequently asked questions about Endocrine therapy + Abemaciclib
What is Endocrine therapy + Abemaciclib?
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What does Endocrine therapy + Abemaciclib target?
Related
- Drug class: All CDK4/6 inhibitor + endocrine therapy combination drugs
- Target: All drugs targeting CDK4/6 (abemaciclib component); estrogen receptor (endocrine therapy component)
- Manufacturer: Japanese Foundation for Cancer Research — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (in combination with endocrine therapy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing