Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions over exon 21 (L858R) substitution variants. This indication is based on the randomized, open-label, active-controlled trial FLAURA2 where the treatment arm with chemotherapy was investigator's choice of cisplatin (75 mg/m^2) or carboplatin (AUC).
This is written in the approval document as:
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
Citation
AstraZeneca AB. Tagrisso (osimertinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf. Revised July 2024. Accessed August 22, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Cisplatin, Osimertinib | |
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Carboplatin, Osimertinib | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Cisplatin, Osimertinib | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Carboplatin, Osimertinib |