2024 FDA EGFR-mutated NSCLC approvals relevant to CCL

类型: 权威资料 发表日期: 2024-09-25 入库日期: 2026-05-21 来源: FDA 标签: FDA, EGFR L858R, 奥希替尼, Amivantamab, Lazertinib, 药物可及性

Why this is in CCL

FDA pages are not treatment guidelines, but they are authoritative for approved indications and pivotal trial anchors. They help distinguish “published evidence”, “approved indication”, and “clinical-trial-only idea”.

Key approvals and links

1. Osimertinib + platinum chemotherapy for locally advanced/metastatic EGFR exon 19 deletion or L858R NSCLC.

   • FDA: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-osimertinib-chemotherapy-egfr-mutated-non-small-cell-lung-cancer
   • Trial: FLAURA2.

2. Lazertinib + amivantamab for first-line locally advanced/metastatic EGFR exon 19 deletion or L858R NSCLC.

   • FDA: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lazertinib-amivantamab-vmjw-non-small-lung-cancer
   • Trial: MARIPOSA.

3. Amivantamab + carboplatin/pemetrexed after progression on or after EGFR TKI for EGFR exon 19 deletion or L858R NSCLC.

   • FDA: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-amivantamab-vmjw-carboplatin-and-pemetrexed-non-small-cell-lung-cancer-egfr-exon-19
   • Trial: MARIPOSA-2.

4. Osimertinib after chemoradiotherapy for unresectable stage III EGFR-mutated NSCLC.

   • FDA/label context and PubMed: https://pubmed.ncbi.nlm.nih.gov/38828946/
   • Trial: LAURA.

Practical relevance

• Mom’s mutation, EGFR L858R, is explicitly represented in these indications.
• Post-osimertinib strategy should be separated into: confirmed progression, resistance mechanism, availability in China/US, toxicity tolerance, and whether the evidence applies after her exact prior regimen.