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Pembrolizumab
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 8.2.3. Immunomodulators
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Rejected
ATC codes: L01FF02
Indication
Other specified malignant neoplasms of bronchus or lung ICD11 code: 2C75.Y
INN
Pembrolizumab
Medicine type
Biological agent
List type
Complementary
Formulations
Parenteral > General injections > IV: 50 mg powder for injection
EML status history
Application rejected in 2019 (TRS 1021)
Application rejected in 2021 (TRS 1035)
Application rejected in 2023 (TRS 1049)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
atezolizumab (ATC codes: L01FF05)
nivolumab (ATC codes: L01FF01)
cemiplimab (ATC codes: L01FF06)
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
Pembrolizumab
DrugBank
Pembrolizumab
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend addition of PD-1 and PD-L1 immune checkpoint inhibitors to the EML for the first-line treatment of non-oncogene addicted metastatic NSCLC in patients with tumour PD-L1 expression ≥ 50% (pembrolizumab, atezolizumab, cemiplimab) and of non-oncogene addicted locally advanced, unresectable NSCLC following chemo-radiotherapy in patients with tumour PD-L1 expression ≥1% (durvalumab). As was the case in 2021, the Committee accepted these medicines continue to demonstrate a relevant and meaningful survival benefit for eligible patients, and possible improvements in quality of life compared with platinum-based chemotherapy. The available evidence is particularly strong for pembrolizumab, for which overall survival benefits are maintained over 5 years. Atezolizumab and cemiplimab show similar benefits, although the available follow-up data are shorter. Similarly, durvalumab data are less mature and will require further consideration. The Committee considered that an overall net benefit can be reasonably assumed for the entire class when compared to platinum-based chemotherapies. However, more data are needed regarding the optimal doses and duration of treatment, with some data already suggesting that for several immune checkpoint inhibitors, lower doses and shorter durations may be sufficient. In principle, the Committee considered that the availability of several immune checkpoint inhibitors as therapeutic options can boost competition and facilitate affordable access. These considerations notwithstanding, the Committee noted that prices for immune checkpoint inhibitors remain prohibitively high in most settings, and global access to affordable companion diagnostic tests is limited. Coupled with the high global prevalence of non-small cell lung cancer, the opportunity costs of providing treatment with immune checkpoint inhibitors would be substantial for many health systems and would divert limited available resources from other public health programmes. The Expert Committee encouraged WHO to continue to work on strategies to address the issue of high prices of effective cancer medicines and identify solutions to facilitate increased affordable access.