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Non-small cell lung cancer

Oncology 30 original drugs
30
Novel Drugs
10
Reformulations
0
Active Trials
59
Drug Targets

Oncology indication. Non-small cell lung cancer has 30 FDA-approved novel treatments, led by Bristol-Myers Squibb across 59 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Non-small cell lung cancer Market Leaders

Companies with the most FDA-approved novel Non-small cell lung cancer drugs.

#1
Bristol-Myers Squibb
4
original drugs
#2
Roche
3
original drugs
#3
Novartis
2
original drugs

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

Full calendar →
Q3 2026
SSGJ-707
Shenyang Sunshine Pharmaceutical Co., LTD.
Estimated · stale NCT06980272
Q3 2026
pembrolizumab/vibostolimab
Merck
Estimated · aging NCT05298423
Q3 2026
JDQ443
Novartis
Estimated · fresh NCT05132075
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Non-small cell lung cancer Treatments by Mechanism

Top 12 mechanisms across 199 industry trials with a known mechanism of action.

See full pipeline →
Programmed Death Receptor-1 Blocking Antibody
81 trials 15 active 12 sponsors
Programmed Death Ligand-1 Blocker
27 trials 14 active 8 sponsors
Kinase Inhibitor
37 trials 13 active 16 sponsors
KRAS G12C
5 trials 3 active 2 sponsors
Dihydrofolate reductase/Folylpolyglutamate Synthetase/Glycinamide Ribonucleotide Formyltransferase/Thymidylate Synthase
23 trials 2 active 6 sponsors
Vascular Endothelial Growth Factor Inhibitor
9 trials 2 active 7 sponsors
ALK/ROS1/NTRK1/TRKB/TRKC
2 trials 2 active 1 sponsor
Vascular Endothelial Growth Factor Receptor 2 Antagonist
8 trials 1 active 1 sponsor
DNA
3 trials 1 active 3 sponsors
AXL/FLT-3/KIT/MER/MET/RET/ROS1/TIE-2/TRKB/TYRO3/VEGFR-1/VEGFR-2/VEGFR-3
2 trials 1 active 2 sponsors
EGFR/ERBB2
1 trials 1 active 1 sponsor
Corticosteroid
1 trials 1 active 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Non-small cell lung cancer Clinical Pipeline by Phase

1801 industry-sponsored trials across 562 sponsors

Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Non-small cell lung cancer

HER2 (20) VEGF (17) RET (12) ROS1 (11) EGFR (11) FLT3 (10)

Novel Non-small cell lung cancer Drugs by Company (New molecular entities)

19 companies have an FDA-approved novel drug for Non-small cell lung cancer.

Bristol-Myers Squibb 4 drugs
OPDIVO QVANTIG
NIVOLUMAB
BLA 2024
AUGTYRO
REPOTRECTINIB
NDA 2023
OPDIVO
NIVOLUMAB
BLA 2014
YERVOY
IPILIMUMAB
BLA 2011
Roche 3 drugs
TECENTRIQ
ATEZOLIZUMAB
BLA 2016
ALECENSA
ALECTINIB HYDROCHLORIDE
NDA 2015
AVASTIN
BEVACIZUMAB
BLA 2004
Novartis 2 drugs
ZYKADIA
CERITINIB
NDA 2014
TAFINLAR
DABRAFENIB MESYLATE
NDA 2013
AstraZeneca 2 drugs
IMJUDO
TREMELIMUMAB-ACTL
BLA 2022
IMFINZI
DURVALUMAB
BLA 2017
Boehringer Ingelheim 2 drugs
HERNEXEOS
ZONGERTINIB
NDA 2025
GILOTRIF
AFATINIB DIMALEATE
NDA 2013
Pfizer 2 drugs
LORBRENA
LORLATINIB
NDA 2018
VIZIMPRO
DACOMITINIB
NDA 2018
Merck 2 drugs
KEYTRUDA QLEX
PEMBROLIZUMAB
BLA 2025
KEYTRUDA
PEMBROLIZUMAB
BLA 2014
Eli Lilly 2 drugs
RETEVMO
SELPERCATINIB
NDA 2020
CYRAMZA
RAMUCIRUMAB
BLA 2014
NUVATION 1 drug
IBTROZI
TALETRECTINIB ADIPATE
NDA 2025
MERUS N.V. 1 drug
BIZENGRI
ZENOCUTUZUMAB-ZBCO
BLA 2024
+9 more companies
Reformulations (10 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.

RYBREVANT FASPRO
Johnson & Johnson
T5 2025
AVGEMSI
AVYXA HOLDINGS
T5 2025
BEIZRAY
ZHUHAI
T5 2024
TECENTRIQ HYBREZA
Roche
T3 2024
DOCIVYX
AVYXA HOLDINGS
T5 2022
PEMFEXY
EAGLE PHARMS
T5 2020
MEKTOVI
ARRAY BIOPHARMA INC
T1 2018
MEKINIST
Novartis
T1 2013
ALIMTA
Eli Lilly
T1 2004
PEMETREXED FOR INJECTION
Dr. Reddy's

Non-small cell lung cancer Drug Targets

Molecular targets of approved and investigational Non-small cell lung cancer drugs — 59 targets tracked.

EGFR 8 ROS1 7 Dihydrofolate reductase 6 Folylpolyglutamate Synthetase 6 Glycinamide Ribonucleotide Formyltransferase 6 Thymidylate Synthase 6 ALK 6 VEGFA 6 ERBB2 5 Hyaluronan 4 PDCD1 4 NTRK1 3 TRKB 3 TRKC 3 CD274 3 +44 more
Biosimilars (6 BLA approved) Click to expand

Biosimilars are biological products highly similar to FDA-approved reference biologics with no clinically meaningful differences in safety, purity, or potency.

JOBEVNE
BIOCON BIOLOGICS INC
2025
AVZIVI
BIO-THERA SOLUTIONS LTD
2023
VEGZELMA
CELLTRION INC
2022
ALYMSYS
AMNEAL PHARMS
2022
ZIRABEV
Pfizer
2019
MVASI
Amgen
2017
Generic Drugs (6 ANDA approved) Click to expand

Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).

DOCETAXEL
ACCORD HLTHCARE
ERLOTINIB HYDROCHLORIDE
SHILPA
GEFITINIB
Teva
GEMCITABINE HYDROCHLORIDE
Pfizer
PEMETREXED
BIOCON LTD
PEMETREXED DISODIUM
Apotex

Related Indications

Other Oncology indications

View all Oncology

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology