Lorlatinib
Also known as Lorbrena
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
NDA210868,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- PFIZER INC PFE Source: Company record for PFIZER INC (opens in a new tab)
- Indication
- Carcinoma, Non-Small-Cell Lung Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 210868 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 210868 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 27 Apr 20171 linked trial
- Filed Completed
- Approved Current stageFirst approval 2 Nov 2018
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Lorlatinib. Editors add each one with its source.
Filed application
No filed application is on record for Lorlatinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Lorlatinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT03052608ClinicalTrials.gov record for NCT03052608 (opens in a new tab) | A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC | Phase 3 | Active, not recruiting | 296 (actual) | 20 Mar 2020 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03052608 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03052608
Serious adverse events (From the first dose of study treatment through end of study follow-up (infinite lag) or start of new anti-cancer therapy, whichever occurred first (assessed up to 33 months).): Lorlatinib 51 of 149; Crizotinib 39 of 142 Source: ClinicalTrials.gov results for NCT03052608 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03052608 (13), newest first
All 13 publications for NCT03052608 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA210868Action letter for NDA210868 (opens in a new tab) | Supplement 4 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA210868Action letter for NDA210868 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Lorviqua (EMEA/H/C/004646)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Active substance (INN)
- lorlatinib
- ATC code
- L01ED05
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Lorviqua (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 210868 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03052608 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA210868 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.