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Lorlatinib post Radiation (lorlatinib-post-radiation)

Pfizer Inc. · Phase 1 active Quality 0/100

Lorlatinib post Radiation (generic name: lorlatinib-post-radiation) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.

Lorlatinib post-Radiation is an investigational Phase 1 study by Pfizer examining lorlatinib, a third-generation ALK inhibitor, in patients who have received prior radiation therapy. Lorlatinib is a potent, selective ALK tyrosine kinase inhibitor with superior brain penetration due to its reduced efflux transporter substrate activity, enabling effective CNS disease control. The parent compound is FDA-approved for ALK-positive non-small cell lung cancer (NSCLC), particularly in patients with prior ALK inhibitor resistance or brain metastases. This post-radiation study investigates potential synergies or safety considerations when combining ALK inhibition with radiation therapy, a clinically relevant question given the high incidence of brain metastases in ALK+ NSCLC. The commercial significance is substantial given lorlatinib's established market position and the large ALK+ NSCLC patient population; understanding radiation interactions could expand treatment paradigms. This Phase 1 investigation represents a precision oncology approach to optimizing multimodal therapy in advanced lung cancer.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Big-pharma sponsor +3.0pp
    Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic namelorlatinib-post-radiation
SponsorPfizer Inc.
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Lorlatinib post Radiation

What is Lorlatinib post Radiation?

Lorlatinib post Radiation (lorlatinib-post-radiation) is a pharmaceutical drug developed by Pfizer Inc..

Who makes Lorlatinib post Radiation?

Lorlatinib post Radiation is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of Lorlatinib post Radiation?

lorlatinib-post-radiation is the generic (nonproprietary) name of Lorlatinib post Radiation.

What development phase is Lorlatinib post Radiation in?

Lorlatinib post Radiation is in Phase 1.

Related

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