KISQALI FEMARA CO-PACK (COPACKAGED)

Peak

letrozole and ribociclib

NDAORALTABLET
Approved
May 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
59

Mechanism of Action

cyclin-dependent kinase (CDK) 4 and 6. These kinases are activated upon binding to D-cyclins and are downstream of signaling pathways, which lead to cell cycle progression and cellular proliferation. The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the…

Indications (1)

Clinical Trials (5)

NCT07288359Phase 1/2Recruiting

Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Started Dec 2025
205 enrolled
Advanced HR+/HER2- Breast CancerAdvanced CCNE1-amplified Solid TumorsMetastatic Castration-resistant Prostate Cancer
NCT06930859N/ARecruiting

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

Started Dec 2025
2,766 enrolled
Breast Cancer
NCT05827081Phase 3Recruiting

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Started Feb 2024
1,400 enrolled
Early Breast Cancer
NCT05467891Phase 2Recruiting

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Started Sep 2022
200 enrolled
Locoregional RecurrenceHormone Receptor-positive Breast CancerHER2-negative Breast Cancer
NCT05161195Phase 4Active Not Recruiting

Roll-over Study to Allow Continued Access to Ribociclib

Started Jul 2022
134 enrolled
Metastatic Breast Cancer

Loss of Exclusivity

LOE Date
Apr 14, 2036
123 months away
Patent Expiry
Apr 14, 2036
Exclusivity Expiry
Sep 17, 2027

Patent Records (5)

Patent #ExpiryTypeUse Code
8324225
Jun 17, 2028
SubstanceProduct
9416136
Aug 20, 2029
U-3264
8962630
Dec 9, 2029
U-3264
8685980
May 25, 2030
SubstanceProduct
8415355
Mar 13, 2031
SubstanceProduct