OnCo
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Ribociclib

Ribociclib is the CDK4/6 inhibitor with the most consistent survival benefit, approved for a broad population of early breast cancer patients since 2024.

MONALEESA-2/3/7 (OS benefit in all three), NATALEE (adjuvant stage II-III HR+/HER2-, iDFS HR 0.75, approved September 2024). Novartis. QT prolongation and liver enzymes need monitoring.

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Ribociclib
PubChem
Mechanism, step by step
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1.Oral drug is absorbed and reaches the tumour

Modality
Small-molecule CDK4/6 inhibitor
Mechanism
CDK4-biased CDK4/6 inhibitor.
Brand / code
Kisqali
Dosing & schedule
Route
Oral
Schedule
600 mg once daily (advanced) or 400 mg once daily (adjuvant, 3 years) for 21 days then 7 off, with aromatase inhibitor or fulvestrant
Dose modifications
Reduce to 400 then 200 mg for QTc >480 ms, hepatotoxicity, neutropenia
Monitoring
ECG at baseline, day 14 cycle 1, start of cycle 2; LFTs every 2 weeks for 2 cycles; blood counts; avoid strong CYP3A inhibitors and tamoxifen

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Some PBMs designate a preferred CDK4/6 inhibitor.

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA496 · 2017SMC: accepted
Appraised for
With an aromatase inhibitor for untreated HR-positive, HER2-negative advanced breast cancer
Notes
With fulvestrant: TA593 (2019) and TA687 (2021, pre/perimenopausal). Adjuvant use (NATALEE) appraised 2025.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA496 · SMC advice: ribociclib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 13 Mar 2017ApprovalUS

    With aromatase inhibitor, HR+/HER2- advanced breast cancer (MONALEESA-2) source

  2. 18 Jul 2018ApprovalUS

    Pre/perimenopausal women and with fulvestrant (MONALEESA-7/-3) source

  3. 17 Sept 2024ApprovalUS

    Adjuvant stage II-III HR+/HER2- early breast cancer at high risk (NATALEE) source

Approvals

RegionYearIndication
US2017HR+/HER2- advanced breast cancer
US2024Adjuvant stage II-III HR+/HER2- breast cancer at high risk of recurrence

Safety

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Toxicity profile
Adverse eventAny gradeGrade 3+
Neutrophils decreased
NATALEE / MONALEESA-2
94%
45%
Leukocytes decreased
NATALEE / MONALEESA-2
95%
Lymphocytes decreased
NATALEE / MONALEESA-2
97%
Infections
NATALEE / MONALEESA-2
37%
ALT/AST increased (grade 3-4)
8-11% across trials
8%
Nausea
NATALEE / MONALEESA-2
Fatigue
NATALEE / MONALEESA-2
Diarrhoea
NATALEE / MONALEESA-2
QT prolongation
Concentration-dependent; ECG monitoring required

Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part D (oral); commercial plans per formulary, often with prior authorisation
United KingdomNICE: recommended with aromatase inhibitor (TA496), fulvestrant (TA687), and adjuvant (2025)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-06
132 studies32 recruiting67 Phase 233 Phase 3
Search “Ribociclib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Ribociclib
intervention: Ribociclib
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Key papers

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Latest papers

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Literature trend265 papers in the last 12 months+36% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Ribociclib" OR ABSTRACT:"Ribociclib" OR TITLE:"Kisqali" OR ABSTRACT:"Kisqali") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Ribociclib, not a curated reading list.

Connected

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