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
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 |