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CDK 4/6 inhibitors
CDK 4/6 inhibitors block cyclin-dependent kinases 4 and 6, which prevents phosphorylation of the retinoblastoma protein and halts cell cycle progression at the G1/S checkpoint.
CDK 4/6 inhibitors block cyclin-dependent kinases 4 and 6, which prevents phosphorylation of the retinoblastoma protein and halts cell cycle progression at the G1/S checkpoint. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (in combination with endocrine therapy), Hormone receptor-positive, HER2-negative early breast cancer (adjuvant setting, in combination with endocrine therapy).
At a glance
| Generic name | CDK 4/6 inhibitors |
|---|---|
| Sponsor | Region Örebro County |
| Drug class | CDK 4/6 inhibitor |
| Target | CDK4, CDK6 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting CDK4/6 activity, these drugs prevent cancer cells from progressing from the G1 phase into S phase of the cell cycle, effectively stopping tumor cell proliferation. This mechanism is particularly effective in hormone receptor-positive breast cancers that depend on cyclin D-CDK4/6 signaling. CDK4/6 inhibitors are typically used in combination with endocrine therapy to enhance anti-tumor activity.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer (in combination with endocrine therapy)
- Hormone receptor-positive, HER2-negative early breast cancer (adjuvant setting, in combination with endocrine therapy)
Common side effects
- Neutropenia
- Leukopenia
- Anemia
- Nausea
- Fatigue
- Diarrhea
- Vomiting
- Stomatitis
Key clinical trials
- Epidemiology and Treatment of HR+/HER2- Breast Cancer in England
- BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (PHASE3)
- Emotional Distress in Patients With Metastatic Breast Cancer in First Line of Therapy
- Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer. (PHASE2)
- Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers (PHASE4)
- CDK and Body Composition Study
- Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer (PHASE2)
- Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing (NA)
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:
- CDK 4/6 inhibitors CI brief — competitive landscape report
- CDK 4/6 inhibitors updates RSS · CI watch RSS
- Region Örebro County portfolio CI