Home·Know Your Companions™·Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer (NSCLC)

Solid tumorIndication · Lung

NSCLC comprises a group of lung cancers defined by diverse driver mutations such as EGFR, ALK, and KRAS. Many targeted therapies depend on specific biomarker results.

Approvals

83

Therapies

32

Biomarkers

15

Mapped tests

20

Biomarkers used in this indication

Each approval combines this indication with specific biomarker criteria and a therapy. Select a therapy from the tables below to open its FDA-defined testing pathway.

Indication-specific biomarkers

Defined explicitly for Non-Small Cell Lung Cancer (NSCLC) in FDA labeling.

Biomarker	Biomarker criteria	Therapies
ALK	gene rearrangements	ALUNBRIG ENSACOVE XALKORI ALECENSA ZYKADIA
ALK	protein expression	LORBRENA ALECENSA ZYKADIA XALKORI
BRAF	V600E	TAFINLAR + MEKINIST BRAFTOVI + MEKTOVI
EGFR (HER1)	Exon 19 deletion or exon 21 L858R substitution mutation	VIZIMPRO LAZCLUZE + RYBREVANT IRESSA GILOTRIF TAGRISSO TARCEVA
EGFR (HER1)	Exon 19 deletions or exon 21 L858R, and T790M	TAGRISSO
EGFR (HER1)	Exon 20 insertions	ZEGFROVY RYBREVANT
EGFR (HER1)	L861Q, G719X and S7681	GILOTRIF
EGFR (HER1)	T790M	TAGRISSO
ERBB2 (HER2)	Activating Mutations (SNVs And Exon 20 Insertions)	ENHERTU
ERBB2 (HER2)	Activating mutations in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions)	HERNEXEOS
KRAS	G12C	KRAZATI LUMAKRAS
MET	MET protein expression (>= 50% of tumor cells exhibiting strong membrane and/or cytoplasmic staining 3+)	EMRELIS
MET	single nucleotide variants and indels that lead to MET exon 14 skipping	TEPMETKO TABRECTA
PD-L1	protein expression	TECENTRIQ KEYTRUDA
PD-L1	protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%])	TECENTRIQ
PD-L1	protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%])	LIBTAYO
PD-L1	protein expression (tumor cell staining ≥1%)	OPDIVO + YERVOY
PD-L1	protein expression [Tumor Proportion Score (TPS) ≥ 50%]	LIBTAYO
ROS1	fusions	XALKORI ROZLYTREK

Tumor-agnostic biomarkers

Defined at the solid tumor level and applicable to Non-Small Cell Lung Cancer (NSCLC) and other solid tumor cancers.

Biomarker	Biomarker criteria	Therapies
deficient mismatch repair (dMMR) proteins	MLH1, PMS2, MSH2 and MSH6	JEMPERLI KEYTRUDA
MSI-High	Microsatellite instability-High	KEYTRUDA JEMPERLI
NTRK1, NTRK2 and NTRK3	fusions	VITRAKVI ROZLYTREK
RET	fusions	RETEVMO GAVRETO
TMB	TMB ≥ 10 mutations per megabase	KEYTRUDA

Therapies with biomarker-defined approvals

Each therapy below has at least one FDA companion diagnostic approval tied to Non-Small Cell Lung Cancer (NSCLC). Select a therapy to view the specific approval and eligible tests.

Therapy

ALECENSA

alectinib · Genentech

ALK (gene rearrangements); ALK (protein expression)

2 approvalsView testing pathway →

Therapy

ALUNBRIG

brigatinib · Takeda

ALK (gene rearrangements)

1 approvalView testing pathway →

Therapy

BRAFTOVI + MEKTOVI

BRAF (V600E)

1 approvalView testing pathway →

Therapy

EMRELIS

telisotuzumab vedotin-tllv · AbbVie

MET (MET protein expression (>= 50% of tumor cells exhibiting strong membrane and/or cytoplasmic staining 3+))

1 approvalView testing pathway →

Therapy

ENHERTU

fam-trastuzumab deruxtecan-nxki · Daiichi Sankyo, AstraZeneca

ERBB2 (HER2) (Activating Mutations (SNVs And Exon 20 Insertions))

1 approvalView testing pathway →

Therapy

ENSACOVE

ensartinib · Xcovery Holdings, Inc.

ALK (gene rearrangements)

1 approvalView testing pathway →

Therapy

GAVRETO

pralsetinib · Rigel Pharmaceuticals

RET (fusions)

1 approvalView testing pathway →

Therapy

GILOTRIF

afatinib · Boehringer Ingelheim

EGFR (HER1) (Exon 19 deletion or exon 21 L858R substitution mutation); EGFR (HER1) (L861Q, G719X and S7681)

2 approvalsView testing pathway →

Therapy

HERNEXEOS

zongertinib · Boehringer Ingelheim

ERBB2 (HER2) (Activating mutations in the tyrosine kinase domain (SNVs in exons 18-21 and exon 20 insertions))

1 approvalView testing pathway →

Therapy

IRESSA

gefitinib · AstraZeneca

EGFR (HER1) (Exon 19 deletion or exon 21 L858R substitution mutation)

1 approvalView testing pathway →

Therapy

JEMPERLI

dostarlimag-gxly · GSK

deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High)

2 approvalsView testing pathway →

Therapy

KEYTRUDA

pembrolizumab · Merck

PD-L1 (protein expression); deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High); TMB (TMB ≥ 10 mutations per megabase)

4 approvalsView testing pathway →

Therapy

KRAZATI

adagrasib · Bristol Myers Squibb

KRAS (G12C)

1 approvalView testing pathway →

Therapy

LAZCLUZE + RYBREVANT

EGFR (HER1) (Exon 19 deletion or exon 21 L858R substitution mutation)

1 approvalView testing pathway →

Therapy

LIBTAYO

cemiplimab-rwlc · Regeneron

PD-L1 (protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%])); PD-L1 (protein expression [Tumor Proportion Score (TPS) ≥ 50%])

2 approvalsView testing pathway →

Therapy

LORBRENA

lorlatinib · Pfizer

ALK (protein expression)

1 approvalView testing pathway →

Therapy

LUMAKRAS

sotorasib · Amgen

KRAS (G12C)

1 approvalView testing pathway →

Therapy

OPDIVO + YERVOY

PD-L1 (protein expression (tumor cell staining ≥1%))

1 approvalView testing pathway →

Therapy

RETEVMO

selpercatinib · Eli Lilly

RET (fusions)

1 approvalView testing pathway →

Therapy

ROZLYTREK

entrectinib · Genentech

ROS1 (fusions); NTRK1, NTRK2 and NTRK3 (fusions)

2 approvalsView testing pathway →

Therapy

RYBREVANT

amivantamb · Johnson & Johnson

EGFR (HER1) (Exon 20 insertions)

1 approvalView testing pathway →

Therapy

TABRECTA

capmatinib · Novartis

MET (single nucleotide variants and indels that lead to MET exon 14 skipping)

1 approvalView testing pathway →

Therapy

TAFINLAR + MEKINIST

BRAF (V600E)

1 approvalView testing pathway →

Therapy

TAGRISSO

osimertinib · AstraZeneca

EGFR (HER1) (Exon 19 deletion or exon 21 L858R substitution mutation); EGFR (HER1) (Exon 19 deletions or exon 21 L858R, and T790M); EGFR (HER1) (T790M)

3 approvalsView testing pathway →

Therapy

TARCEVA

erlotinib · Genentech

EGFR (HER1) (Exon 19 deletion or exon 21 L858R substitution mutation)

1 approvalView testing pathway →

Therapy

TECENTRIQ

atezolizumab · Genentech

PD-L1 (protein expression); PD-L1 (protein expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]))

2 approvalsView testing pathway →

Therapy

TEPMETKO

tepotinib · Merck KGaA

MET (single nucleotide variants and indels that lead to MET exon 14 skipping)

1 approvalView testing pathway →

Therapy

VITRAKVI

larotrectinib · Bayer

NTRK1, NTRK2 and NTRK3 (fusions)

1 approvalView testing pathway →

Therapy

VIZIMPRO

dacomitinib · Pfizer

EGFR (HER1) (Exon 19 deletion or exon 21 L858R substitution mutation)

1 approvalView testing pathway →

Therapy

XALKORI

crizotinib · Pfizer

ALK (gene rearrangements); ALK (protein expression); ROS1 (fusions)

3 approvalsView testing pathway →

Therapy

ZEGFROVY

sunvozertinib · Dizal Pharmaceutical

EGFR (HER1) (Exon 20 insertions)

1 approvalView testing pathway →

Therapy

ZYKADIA

ceritinib · Novartis

ALK (gene rearrangements); ALK (protein expression)

2 approvalsView testing pathway →

This indication view is scoped to Non-Small Cell Lung Cancer (NSCLC). You can also explore how it appears alongside other cancers in Know Your Companions™ by searching or filtering on the main map.