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(CDK)4/6 inhibitor
CDK4/6 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.
CDK4/6 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 breast cancer (likely indication based on CDK4/6 inhibitor class).
At a glance
| Generic name | (CDK)4/6 inhibitor |
|---|---|
| Also known as | ET, Palbociclib；, Abemaciclib / Ribociclib / Palbociclib |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Drug class | CDK4/6 inhibitor |
| Target | CDK4, CDK6 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
CDK4/6 inhibitors are small molecules that bind to and inhibit cyclin-dependent kinases 4 and 6, enzymes critical for driving cells from G1 phase into S phase of the cell cycle. By preventing retinoblastoma protein phosphorylation, these inhibitors cause cell cycle arrest in cancer cells, particularly in hormone receptor-positive breast cancer. This mechanism is often used in combination with endocrine therapy to enhance anti-tumor activity.
Approved indications
- Hormone receptor-positive, HER2-negative breast cancer (likely indication based on CDK4/6 inhibitor class)
Common side effects
- Neutropenia
- Leukopenia
- Anemia
- Diarrhea
- Nausea
- Fatigue
Key clinical trials
- 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
- A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma (PHASE2)
- A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy (PHASE2)
- OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (PHASE3)
- 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 Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer (PHASE2)
- Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer. (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:
- (CDK)4/6 inhibitor CI brief — competitive landscape report
- (CDK)4/6 inhibitor updates RSS · CI watch RSS
- Tianjin Medical University Cancer Institute and Hospital portfolio CI