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Exon 20 insertions add amino acids after the C-helix of EGFR and make the kinase resistant to the usual EGFR tablets. They account for about a tenth of EGFR mutations and have their own drugs: amivantamab with chemotherapy and sunvozertinib.
In-frame insertions or duplications in exon 20 (A767_V769dup, D770_N771insSVD and others) are structurally distinct from the classical mutations and do not respond to first- or third-generation TKIs at tolerated doses. Amivantamab is labelled with carboplatin and pemetrexed for first-line NSCLC with EGFR exon 20 insertion mutations (PAPILLON) and alone after platinum chemotherapy; sunvozertinib (Zegfrovy, 2025) is labelled after platinum chemotherapy with the Oncomine Dx Express Test as companion; mobocertinib was withdrawn in 2023. Guardant360 CDx and the Oncomine Dx Target Test carry exon 20 insertion claims for amivantamab. PCR hotspot kits miss many exon 20 insertions, so sequencing is preferred.
In plain words · A growth receptor that is mutated in some lung cancers and overproduced in others; the first great success of targeted pills.
An exon 20 insertion is an EGFR mutation that the common EGFR tablets do not treat well. The on-label first treatment is amivantamab with chemotherapy; after chemotherapy, amivantamab alone or sunvozertinib. Make sure the mutation was found by sequencing, because older hotspot tests can miss it.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
An in-frame insertion or duplication within exon 20 of EGFR (excluding T790M) detected by next-generation sequencing of tumour tissue or plasma.
“Exon 20 insertion mutations”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| EGFR exon 20 insertion Rybrevant indications 1.2 and 1.3: with carboplatin and pemetrexed for first-line, and as a single agent after platinum chemotherapy, in NSCLC with EGFR exon 20 insertion mutations as detected by an FDA-approved test. | Amivantamab | Non-small-cell lung cancer | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| Guardant360 CDx | Guardant Health | Non-Small Cell Lung Cancer (NSCLC) - Plasma | Amivantamab | P200010/S001 (05/21/2021) |
| Oncomine Dx Target Test | Life Technologies (Thermo Fisher Scientific) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Amivantamab | P160045/S027 (12/01/2021) |
| Oncomine Dx Express Test | Life Technologies (Thermo Fisher Scientific) | Non-Small Cell Lung Cancer (NSCLC) - Tissue | Sunvozertinib | P240040 (07/02/2025) |
Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.
Shares EGFR exon 19 deletion, EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, Amivantamab and the tags biomarker, egfr.
Shares EGFR exon 19 deletion, EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, EGFR and the tags biomarker, egfr.
Shares EGFR exon 19 deletion, EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M), EGFR, Non-small-cell lung cancer and the tag biomarker.
Shares Oncomine Dx Target Test, Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, Non-small-cell lung cancer and the tag biomarker.
Shares Oncomine Dx Target Test, Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, Non-small-cell lung cancer and the tag biomarker.
Shares Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors, Next-generation sequencing (NGS), Non-small-cell lung cancer and the tag biomarker.
Shares Oncomine Dx Target Test, Next-generation sequencing (NGS) and the tag biomarker.
Shares Guardant360 CDx, Next-generation sequencing (NGS), Non-small-cell lung cancer and the tag biomarker.