Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to tremelimumab-actl in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. This indication is based on POSEIDON (NCT03164616), a randomized, open-label, multicenter, active-controlled trial where patients received one of the following chemotherapy regimens: 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:
IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Citation
AstraZeneca AB. Imjudo (tremelimumab-actl) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf. Revised November 2022. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Durvalumab, Pemetrexed, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Durvalumab, Pemetrexed, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Durvalumab, Gemcitabine, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Durvalumab, Gemcitabine, Tremelimumab | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Durvalumab, Nab-paclitaxel, Tremelimumab |