Also known as: Kisqali
Ribociclib is marketed as KISQALI, a CDK4/6 inhibitor used in hormone receptor-positive, HER2-negative breast cancer settings. The label includes adjuvant use with an aromatase inhibitor in high-risk stage II/III early breast cancer and multiple advanced/metastatic endocrine-based combination settings. U.S. initial approval was in 2017.
Novartis is emphasizing innovative medicines across oncology, immunology, neuroscience and gene therapy. The company targets mid-single-digit sales growth through 2027 and core operating income margins above 35%.
The FDA announced major policy changes including requiring only one study for drug approvals instead of two, and offering performance bonuses to reviewers who complete work ahead of schedule while maintaining thoroughness.
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
The global biopharmaceutical industry entered 2026 facing one of the largest waves of patent expirations in its history, with $200-300 billion in yearly sales at risk through 2032 as major drugs lose exclusivity.
CDK4/6 inhibitors have transformed HR+/HER2− breast cancer treatment, while emerging resistance mechanisms are driving development of selective CDK2 inhibitors and dual CDK2/4 strategies to address treatment failure.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07492641 |
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 |
RECRUITING | PHASE3 |
| NCT07487129 |
Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt |
COMPLETED | PHASE4 |
| NCT07405801 |
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer |
RECRUITING | PHASE2 |
| NCT07195227 |
Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07174336 |
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) |
RECRUITING | PHASE3 |
| NCT07085767 |
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer |
RECRUITING | PHASE3 |
| NCT07054190 |
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer |
RECRUITING | PHASE2 |
| NCT06930859 |
Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia |
RECRUITING | |
| NCT06905301 |
Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice |
RECRUITING | |
| NCT06805812 |
Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study |
RECRUITING |
