FDA Approval Summary: Osimertinib for adjuvant treatment of surgically resected non-small cell lung cancer, a collaborative Project Orbis review

Cette étude analyse les données des essais cliniques ayant conduit la FDA à autoriser l'utilisation de l'osimertinib en traitement adjuvant chez des patients atteints d'un cancer du poumon non à petites cellules ayant été réséqué

Résumé en anglais

On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib as adjuvant therapy in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. The approval was based on the ADAURA study in which 682 patients with NSCLC were randomized to receive osimertinib (n=339) or placebo (n=343). Disease free survival (DFS) in the overall population (Stage IB-IIIA) was improved for patients who received osimertinib, with a hazard ratio (HR) of 0.20; 95% CI: 0.15, 0.27; p<0.0001. Median DFS was not reached for the osimertinib arm compared to 27.5 months (95% CI: 22.0, 35.0) for patients receiving placebo. Overall survival (OS) data was not mature at the time of the approval. This application was reviewed under FDA's Project Orbis, in collaboration with Australia Therapeutic Goods Administration (TGA), Brazil ANVISA, Health Canada, Singapore Health Sciences Authority (HSA), Switzerland Swissmedic, and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). This is the first targeted therapy adjuvant approval for NSCLC and has practice changing implications.