Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic 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. This indication is based on FLAURA2 (NCT04035486), a randomized, multicenter, and open-label trial where patients were randomized to receive either osimertinib or osimertinib in combination with pemetrexed and investigator's choice of either cisplatin or carboplatin.
This is written in the approval document as:
TAGRISSO is a kinase inhibitor indicated in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
Citation
AstraZeneca Pharmaceuticals, LP. Tagrisso (osimertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208065s033lbl.pdf. Revised September 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 (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Cisplatin, Osimertinib, Pemetrexed | |
| Sensitivity (+) | EGFR p.L858R | Non-Small Cell Lung Cancer | Carboplatin, Osimertinib, Pemetrexed | |
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Carboplatin, Osimertinib, Pemetrexed | |
| Sensitivity (+) | EGFR Exon 19 (Deletion) | Non-Small Cell Lung Cancer | Cisplatin, Osimertinib, Pemetrexed |