Regulatory approval
Published by the European Medicines Agency. Withdrawn
The European Medicines Agency (EMA) has authorized tremelimumab in combination with durvalumab and platinum-based chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing EGFR mutations or ALK-positive mutations. This indication is based on POSEIDON, a randomized, open-label, and multicenter study where patients received one of the following chemotherapy regimes: Pemetrexed in combination with carboplatin or cisplatin for patients with non-squamous NSCLC, gemcitabine with cisplatin or carboplatin for patients with squamous NSCLC, and nab-paclitaxel with carboplatin for either non-squamous or squamous NSCLC.
This is written in the approval document as:
Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies |
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Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-09-05 | Van Allen lab | On 2023-11-06, the European Commission withdrew the market authorization for Tremelimumab AstraZeneca (tremelimumab) in the European Union at the request of the marketing authorization holder, AstraZeneca AB, due to their decision to permanently discontinue the marketing of the product for commercial reasons. |
| 2024-10-20 | Van Allen lab | Adding EMA approvals for use to database |
| 2023-02-20 | European Medicines Agency | Indication received approval from the European Commission. |