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Osimertinib
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: L01EB04
Indication
Other specified malignant neoplasms of bronchus or lung ICD11 code: 2C75.Y
INN
Osimertinib
Medicine type
Chemical agent
List type
Complementary
Formulations
Oral > Solid: 40 mg (as mesylate) ; 80 mg (as mesylate)
EML status history
Application rejected in 2021 (TRS 1035)
Application rejected in 2023 (TRS 1049)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
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
Osimertinib
DrugBank
Osimertinib
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommended addition of osimertinib on the EML for first-line treatment of EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The Committee acknowledged that current data show meaningful survival benefits for osimertinib, a third-generation tyrosine kinase inhibitor, compared to first- and second-generation EML-listed alternatives for this indication (erlotinib, gefitinib and afatinib). However, the Committee noted that osimertinib remains very highly priced, and as such would still be unaffordable in many low- and middle-income countries. The Committee expressed concern that the inclusion of osimertinib on the EML could worsen health inequity by diverting limited resources from less expensive alternatives (including generics) already listed on the EML for this indication. The Committee requested that data for osimertinib continue to be evaluated as they evolve and encouraged efforts to facilitate affordable access to osimertinib in low- and middle-income settings e.g., through negotiation of public health licensing agreements through the Medicines Patent Pool.