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CDK4/6 inhibitors

Oncologyยท 4 reviewed drugsยท 9122 cited findings behind them

What the regulatory reviews cover

The CDK4/6 inhibitors reviewed in this library include Kisqali (Novartis AG), Ibrance (Pfizer Inc.), VERZENIO (Eli Lilly and Company), and palbociclib (Pfizer Inc.). These drugs have been reviewed for various indications related to hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer.

Kisqali was reviewed for the adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence, with a hazard ratio (95% CI) for iDFS of 0.749 (0.628, 0.892). Ibrance was reviewed for HR-positive, HER2-negative advanced or metastatic breast cancer, showing a median progression-free survival (IBRANCE plus Letrozole) of 24.8 months compared to 14.5 months for Placebo plus Letrozole. VERZENIO, in combination with fulvestrant, was reviewed for HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy, demonstrating a median progression-free survival (PFS) (abemaciclib + fulvestrant) of 16.4 months versus 9.3 months for placebo + fulvestrant. Palbociclib showed a Median OS (months) - palbociclib arm of 13.04 compared to 8.54 for the comparator arm. It is important to note that these drugs were studied in different trials, and therefore, the reported figures are not directly comparable in a head-to-head manner.

The drugs โ€” one cited result each

Kisqali

Novartis AG

Hazard ratio (95% CI) for iDFS: 0.749 (0.628, 0.892)

Novartis AG โ€” Kisqali FDA Review (NDA/BLA 209092, 2026), p.31

Ibrance

Pfizer Inc.

Median progression-free survival (IBRANCE plus Letrozole): 24.8

PFIZER โ€” Ibrance FDA Review (NDA/BLA 207103, 2019), p.25

VERZENIO

Eli Lilly and Company

median progression-free survival (PFS) (abemaciclib + fulvestrant): 16.4

Eli Lilly and Company โ€” Verzenio FDA Review (NDA208716, ORIG, p.27

palbociclib

Pfizer Inc.

Median OS (months) - palbociclib arm: 13.04

Pfizer Inc. โ€” Ibrance EMA EPAR variation assessment report, p.8

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Oncology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

CDK4/6 inhibitors โ€” 4 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Oncology