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Initiation of ribociclib
CDK4/6 inhibitor
CDK4/6 inhibitor Used for Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.
At a glance
| Generic name | Initiation of ribociclib |
|---|---|
| Sponsor | Shirley Vichy Wang |
| Drug class | CDK inhibitor |
| Target | CDK4/6 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Ribociclib works by inhibiting the cyclin-dependent kinases CDK4 and CDK6, which are involved in the progression of the cell cycle. This leads to a decrease in the proliferation of cancer cells.
Approved indications
- Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Vomiting
- Leukopenia
- Anemia
- Thrombocytopenia
- Neutropenia
- Headache
- Dizziness
Key clinical trials
- Emulation of the MONALEESA-2 Trial Using Specialty Oncology Electronic Health Records Databases
- 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
- RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
- Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer (PHASE2)
- Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer (NA)
- BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer (NA)
- Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors (PHASE1)
- An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
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:
- Initiation of ribociclib CI brief — competitive landscape report
- Initiation of ribociclib updates RSS · CI watch RSS
- Shirley Vichy Wang portfolio CI