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Last reviewed 2026-06-10 · How we verify

ALK-positive metastatic NSCLC without brain metastases — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ALK-positive metastatic NSCLC without brain metastases (disease) competitive landscape: 1 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

1 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating ALK-positive metastatic NSCLC without brain metastases, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	Line of therapy	First approval
Lorlatinib with chemotherapy 2	lorlatinib-with-chemotherapy-2	Pfizer	ALK inhibitor	ALK

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Pfizer · 1 drug in ALK-positive metastatic NSCLC without brain metastases

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Every new regulatory action, PDUFA date, or trial completion in ALK-positive metastatic NSCLC without brain metastases:

Cite this brief

Drug Landscape (2026). ALK-positive metastatic NSCLC without brain metastases — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/alk-positive-metastatic-nsclc-without-brain-metastases. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing