FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review
| Autor: | Elitza Palazov, Yangbing Li, Harpreet Singh, Jeanne Fourie Zirkelbach, Julia A. Beaver, Dianne Spillman, Arūnas Girčys, Jiang Liu, Aleksandr Gamarian, Huiming Xia, Qiuyi Choo, Paz J. Vellanki, Pallavi S. Mishra-Kalyani, Nataliya Fesenko, Nicole Drezner, Ulrich-Peter Rohr, Richard Pazdur, Yuan Li Shen, Xiaoxue Li, Abigail L. Koch |
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| Rok vydání: | 2021 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Lung Neoplasms medicine.medical_treatment Population Placebo Targeted therapy Carcinoma Non-Small-Cell Lung Internal medicine medicine Adjuvant therapy Humans Osimertinib Stage (cooking) education Lung cancer Protein Kinase Inhibitors Acrylamides education.field_of_study Aniline Compounds business.industry medicine.disease ErbB Receptors Mutation business Biomedical sciences |
| Zdroj: | Clinical Cancer Research. 27:6638-6643 |
| ISSN: | 1557-3265 1078-0432 |
| DOI: | 10.1158/1078-0432.ccr-21-1034 |
| Popis: | On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non–small cell lung cancer (NSCLC) whose tumors have 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 an HR of 0.20; 95% confidence interval (CI), 0.15–0.27; P < 0.0001. Median DFS was not reached for the osimertinib arm compared with 27.5 months (95% CI, 22.0–35.0) for patients receiving placebo. Overall survival data were not mature at the time of the approval. This application was reviewed under FDA's Project Orbis, in collaboration with Australia Therapeutic Goods Administration, Brazil ANVISA, Health Canada, Singapore Health Sciences Authority, Switzerland Swissmedic, and the United Kingdom Medicines and Healthcare products Regulatory Agency. This is the first targeted therapy adjuvant approval for NSCLC and has practice-changing implications. |
| Databáze: | OpenAIRE |
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