Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration (FDA) granted approval to durvalumab in combination with platinum-containing chemotherapy for the neoadjuvant treatment, followed by durvalumab as a single agent as adjuvant treatment after surgery, of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This indication is based on AEGEAN (NCT03800134), a randomized, double-blind, placebo-controlled, multicenter trial where the choice of platinum-containing chemotherapy was dependent on tumor histology. Specifically, patients with squamous tumor histology received either carboplatin with paclitaxel or cisplatin with gemcitabine, and patients with non-squamous tumor histology received either pemetrexed with carboplatin or pemetrexed with cisplatin.
This is written in the approval document as:
IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Citation
AstraZeneca UK Limited. Imfinzi (durvalumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf. Revised August 2024. 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, Paclitaxel | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Durvalumab, Gemcitabine | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Cisplatin, Durvalumab, Pemetrexed | |
| Sensitivity (+) | Wild type ALK, Wild type EGFR | Non-Small Cell Lung Cancer | Carboplatin, Durvalumab, Pemetrexed |