PharmaRadar360

PharmaRadar360

OncologyDrug intelligence

Kisqali

Ribociclib

CDK4/6 inhibitor. Developed by Novartis. Clinical, regulatory, and source evidence are connected below.

Company
Novartis
Target / MOA
CDK4 · CDK6
Aliases
Kisqali · LEE011
Signals
21
Clinical trials
13
Approvals
1
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

Phase 3 · RECRUITING · National Cancer Institute (NCI)

clinical trialClinicalTrials.gov

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Phase 3 · RECRUITING · Novartis Pharmaceuticals

clinical trialClinicalTrials.gov

Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

Phase 1 · ACTIVE_NOT_RECRUITING · University of Michigan Rogel Cancer Center

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Kisqali · NDA209092 · label version 28, effective Jul 1, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Early Breast Cancer KISQALI is indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. 1.2 Advanced or Metastatic Breast Cancer KISQALI is indicated for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine-based therapy; or • fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

European Union (EMA)

Kisqali · EMEA/H/C/004213 · Authorised, authorised Aug 22, 2017 (Commission decision C(2017) 5885) · EPAR

Early breast cancer Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.

EMA's summary; the full indication is in the product information on the EPAR page.

Not covered here: Kisqali Femara Co-Pack (NDA209935) (Ribociclib packaged with letrozole; combination products are not covered yet.)

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

NDA209092 · NOVARTIS · first approved Mar 13, 2017

7 efficacy supplements approved

European Union

  • Kisqali: Authorised since Aug 22, 2017

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

NDA209092 (Orange Book)

24 listed patents, latest expiry Oct 14, 2036
  • US 8324225 · expires Jun 17, 2028 · drug substance, drug product
  • US 8324225*PED · expires Dec 17, 2028 · no claim type flagged
  • US 9416136 · expires Aug 20, 2029 · U-2355, U-2356, U-1981, U-3999, U-3266, U-3265, U-3975
  • US 8962630 · expires Dec 9, 2029 · U-1981, U-2356, U-2355, U-3999, U-3265, U-3266, U-3975
  • US 9416136*PED · expires Feb 20, 2030 · no claim type flagged
  • US 8685980 · expires May 25, 2030 · drug substance, drug product
  • US 8962630*PED · expires Jun 9, 2030 · no claim type flagged
  • US 8685980*PED · expires Nov 25, 2030 · no claim type flagged
  • US 8415355 · expires Mar 13, 2031 · drug substance, drug product
  • US 8415355*PED · expires Sep 13, 2031 · no claim type flagged
  • US 9193732 · expires Nov 9, 2031 · drug substance, drug product
  • US 9868739 · expires Nov 9, 2031 · U-2355, U-2356, U-3999, U-1981, U-3975, U-3265, U-3266
  • US 9193732*PED · expires May 9, 2032 · no claim type flagged
  • US 9868739*PED · expires May 9, 2032 · no claim type flagged
  • US 12544379 · expires Aug 7, 2034 · U-3975
  • US 12544380 · expires Aug 7, 2034 · U-4404, U-4405
  • US 12544379*PED · expires Feb 7, 2035 · no claim type flagged
  • US 12544380*PED · expires Feb 7, 2035 · no claim type flagged
  • US 10799506 · expires Apr 14, 2036 · drug product
  • US 12064434 · expires Apr 14, 2036 · drug product
  • US 12419894 · expires Apr 14, 2036 · drug product
  • US 10799506*PED · expires Oct 14, 2036 · no claim type flagged
  • US 12064434*PED · expires Oct 14, 2036 · no claim type flagged
  • US 12419894*PED · expires Oct 14, 2036 · no claim type flagged

Exclusivity: I-950 until Sep 17, 2027; PED until Mar 17, 2028; M-14 until Jul 1, 2029; PED until Jan 1, 2030 · Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

*PED is FDA's mark for a patent's period extended by six months of pediatric exclusivity.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 13 linked records.

Phase 3RECRUITINGNCT07391774

Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

National Cancer Institute (NCI) · Updated Oct 16, 2026

Phase 3RECRUITINGNCT05827081

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Novartis Pharmaceuticals · Updated Oct 16, 2026

Phase 1ACTIVE NOT RECRUITINGNCT05996107

Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

University of Michigan Rogel Cancer Center · Updated Oct 15, 2026

Phase 2TERMINATEDNCT05625087

Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib

UNICANCER · Updated Oct 14, 2026

N/AACTIVE NOT RECRUITINGNCT07710716

A Real-World Study of Clinical Adoption, Treatment Patterns and Tolerability of Adjuvant Ribociclib in HR+/HER2- Early Breast Cancer Patients

Novartis Pharmaceuticals · Updated Oct 13, 2026

Phase 3ACTIVE NOT RECRUITINGNCT04055493

Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

Women's Cancer Study Group GmbH · Updated Oct 9, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

KISQALI

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 16, 202620FDAofficial · Latest Jul 1, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.