<p>On 28 June 2024, the European Commission withdrew the marketing authorisation for Pemetrexed Krka (Pemetrexed) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, KRKA, d.d., Novo mesto, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. </p><p>Pemetrexed Krka was granted marketing authorisation in the EU on 22 May 2018 for treatment of malignant pleural mesothelioma and non-small cell lung cancer 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 2023. The product had not been marketed in the EU since 2022. </p><p>Pemetrexed Krka is a generic medicine of Alimta. There are other generic medicinal products of Alimta authorised and marketed in the EU. </p><p>The European Public Assessment Report (EPAR) for Pemetrexed Krka is updated to indicate that the marketing authorisation is no longer valid.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p><strong>Malignant pleural mesothelioma</strong></p> <p>Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.</p> <p><strong>Non-small cell lung cancer</strong></p> <p>Pemetrexed Krka 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.</p> <p>Pemetrexed Krka 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.</p> <p>Pemetrexed Krka 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.</p></div>
Therapeutic Area (MeSH)
ATC Code
L01BA04
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| pemetrexed disodium | N/A | pemetrexed disodium |
EMA Name
Pemetrexed Krka
Medicine Name
Pemetrexed Krka
Aliases
N/ANo risk management plan link.
