On 9 October, the European Commission withdrew the marketing authorisation for Pemetrexed Sandoz (pemetrexed) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sandoz GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. Pemetrexed Sandoz was granted marketing authorisation in the EU on 18 September 2015 for the treatment of malignant pleural mesothelioma and non-small cell lung cancer. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2020. The product had not been marketed in the EU since 2024. Pemetrexed Sandoz is a generic medicine of Alimta. There are other generic medicinal products of Alimta authorised and marketed in the EU. The European Public Assessment Report (EPAR) for Pemetrexed Sandoz is updated to indicate that the marketing authorisation is no longer valid.
Therapeutic Indication
### Therapeutic indication **Malignant pleural mesothelioma** Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. **Non-small cell lung cancer** Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed Sandoz is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Therapeutic Area (MeSH)
ATC Code
L01BA04
ATC Item
pemetrexed
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| pemetrexed disodium hemipentahydrate | N/A | Pemetrexed Disodium Hydrate |
EMA Name
Pemetrexed Sandoz
Medicine Name
Pemetrexed Sandoz
Aliases
N/A