Export

Palbociclib
The Expert Committee, after evaluation, declines to list the medicine proposed in the application.
The Model List of Essential Medicines reports reasons that Committee Members have identified for denying listing.
Rejected
Section:
8. Immunomodulators and antineoplastics 8.2. Antineoplastics and supportive medicines 8.2.2. Targeted therapies
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Rejected
ATC codes: L01EF01
Indication
Other specified malignant neoplasms of breast ICD11 code: 2D1Y
INN
Palbociclib
Medicine type
Chemical agent
List type
Complementary
Formulations
Oral > Solid: 75 mg ; 100 mg ; 125 mg
EML status history
Application rejected in 2021 (TRS 1035)
Application rejected in 2023 (TRS 1049)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
abemaciclib (ATC codes: L01EF03)
ribociclib (ATC codes: L01EF02)
Patent information
Main patent is active in several jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Tags
Wikipedia
Palbociclib
DrugBank
Palbociclib
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend inclusion of cyclin-dependent kinase 4/6 inhibitors (abemaciclib, palbociclib and ribociclib) for the treatment of hormone receptor positive/HER2-negative advanced breast cancer. The Committee acknowledged that clinical trial results for this class of medicines in the first- and second-line settings suggest a meaningful survival benefit when added to endocrine therapy compared with endocrine therapy alone. However, the Committee also considered that uncertainties still exist regarding the optimal dose and duration of treatment, and whether clinically significant differences exist between agents within the pharmacological class. As in 2021, the Committee noted the enduring high prices of these medicines, which would pose serious affordability challenges, especially in low- and middle-income countries. The Committee recommended that data for these medicines continue to be evaluated as they evolve and reiterated the recommendation of the 2021 Expert Committee that this class of medicines be flagged to the Medicines Patent Pool as potential candidates for voluntary licensing agreements.