Lorbrena

(Lorlatinib)

ApprovedSmall molecule

Lorbrena is a small molecule that works as ALK Tyrosine Kinase Receptor Inhibitor; EML4-ALK Inhibitor.[2] It is being used across 17 indications, with its most advanced program in Approved.[1]

Lorbrena is one of 450 small molecule programs targeting Metastasis. It is currently in Approved.

Indications

Total Trials

Active Trials

449

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

MetastasisNot yet recruiting

Erectile DysfunctionActive, not recruiting

Anaplastic Large Cell LymphomaApproved

NeuroblastomaActive, not recruiting

Kidney DiseaseApproved

Liver DiseaseApproved

Non-Small Cell Lung CancerActive, not recruiting

Small Cell Lung CancerCompleted

GanglioneuroblastomaRecruiting

Advanced Non-Small Cell Lung CancerRecruiting

MetastasisPhase 2

Not yet recruiting

Erectile DysfunctionPreclinical

Active, not recruiting

Anaplastic Large Cell LymphomaApproved

Approved

NeuroblastomaPreclinical

Active, not recruiting

Kidney DiseaseApproved

Approved

Liver DiseaseApproved

Approved

Non-Small Cell Lung CancerApproved

Active, not recruiting

Small Cell Lung CancerApproved

Completed

GanglioneuroblastomaPhase 3

Recruiting

Advanced Non-Small Cell Lung CancerPhase 2

Recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Lorbrena

Pfizer

Approved

15 2

Tepmetko

EMD Serono

Phase 3

4 3

Paclitaxel or Nab-Paclitaxel

AstraZeneca

Phase 3

1 4

Aumolertinib

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3

6 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Lorlatinib

NCT04621188

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03737994

Post-ApprovalNot yet recruiting

Leptomeningeal Metastases

NCT06282874

Active, not recruiting

Non-Small-Cell Lung

NCT07567352

Q2 2027

Phase 2Not yet recruiting

Non-Small Cell Lung Cancer

NCT06682884

Q3 2027

Post-ApprovalNot yet recruiting

Non-Small Cell Lung Cancer

NCT06893354

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer15 trials

Enrolling by invitation·PPeking University Third Hospital··NCT06876675·167 enrolled

Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib

Withdrawn·SSCRI Development Innovations, LLC·Phase 2·NCT05948462

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03737994·10 enrolled

Show 12 more trials

Induction Lorlatinib in Stage III Non-small Cell Lung Cancer

Active, not recruiting·GGuangdong Provincial People's Hospital·Phase 2·NCT05740943·48 enrolled

Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer

Completed· Pfizer logo

Pfizer·Phase 4·NCT04362072·71 enrolled

Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics

Not yet recruiting·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT06893354·20 enrolled

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Completed· Pfizer logo

Pfizer··NCT05834348·5,279 enrolled

Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer

Completed·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT04111705·23 enrolled

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

Completed· Takeda logo

Takeda··NCT03546894·111 enrolled

A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled

Completed· Pfizer logo

Pfizer··NCT06282991·73 enrolled

A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib

Recruiting·CCentro di Riferimento Oncologico - Aviano·Phase 2·NCT06378892·45 enrolled

Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT06682884·25 enrolled

A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer

Active, not recruiting·CCStone Pharmaceuticals·Phase 2·NCT05297890·70 enrolled

LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES

Active, not recruiting· Pfizer logo

Pfizer·Approved·NCT05144997·76 enrolled

A Phase 1/2 Study of Combination Lorlatinib and Ramucirumab in Patients With Advanced ALK-rearranged Lung Cancers

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT06007937·9 enrolled

Lorlatinib8 trials

A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction

Completed· Pfizer logo

Pfizer·Phase 1·NCT05224609·21 enrolled

Lorlatinib - PF-06463922

Approved for marketing· Pfizer logo

Pfizer··NCT03127618

Study of Lorlatinib in ROS1 Rearranged NSCLC

Unknown status·NNational Cancer Center, Korea·Phase 2·NCT03612154·35 enrolled

Show 5 more trials

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT03052608·296 enrolled

Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS)

Active, not recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT04621188·54 enrolled

Single-dose Study of [14C]Lorlatinib (PF-06463922) Metabolism In Healthy Male Volunteers

Completed· Pfizer logo

Pfizer·Phase 1·NCT03184168·6 enrolled

A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China

Completed· Pfizer logo

Pfizer·Phase 2·NCT03909971·109 enrolled

NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)

Completed·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT03107988·65 enrolled

Non-Small Cell Lung Carcinoma4 trials

RETROSPECTIVE CHART REVIEW STUDY OF FIRST LINE LORLATINIB IN LOCALLY ADVANCED/METASTATIC ALK-POSITIVE NON-SMALL CELL LUNG CANCER PATIENTS IN CHINA

Completed· Pfizer logo

Pfizer··NCT07556549·50 enrolled

LOREA : ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF LORLATINIB IN UNTREATED ALK-POSITIVE NSCLC PATIENTS IN A FRENCH NON INTERVENTIONAL STUDY

Recruiting· Pfizer logo

Pfizer·Preclinical·NCT06487078·90 enrolled

A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

Recruiting· Roche logo

Roche·Phase 1·NCT07617337·102 enrolled

Show 1 more trial

Lorlatinib Combined With Sacituzumab Tirumotecan Based on Peripheral Blood ctDNA as First-Line Treatment for Patients With ALK Fusion-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Prospective, Open-Label, Multicenter Study

Not yet recruiting·GGuangdong Association of Clinical Trials·Phase 2·NCT07750704·153 enrolled

Lung Cancer3 trials

Lorlatinib Combinations in Lung Cancer

Unknown status·MMassachusetts General Hospital·Phase 1/2·NCT04292119·96 enrolled

PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer

Unknown status·FFondazione Ricerca Traslazionale·Phase 2·NCT03439215·20 enrolled

A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions

Unknown status·MMassachusetts General Hospital·Phase 2·NCT02927340·30 enrolled

Trial2 trials

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

22 more indications

Small Cell Lung Cancer2 trials

Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India

Completed· Pfizer logo

Pfizer·Phase 4·NCT04541706·100 enrolled

Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

No longer available· Pfizer logo

Pfizer··NCT03178071

Metastasis2 trials

A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis

Active, not recruiting·SSichuan Cancer Hospital and Research Institute··NCT06410040·28 enrolled

Lorlatinib in ROS1+ NSCLC With Brain Metastasis

Not yet recruiting·HHunan Cancer Hospital·Phase 2·NCT07083687·21 enrolled

ALK Positive2 trials

Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT04127110·68 enrolled

A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer

Recruiting·NNuvectis Pharma, Inc.·Phase 1·NCT07784959·54 enrolled

Lymphoma1 trial

A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma

Unknown status·UUniversity of Milano Bicocca·Phase 2·NCT03505554·12 enrolled

Hepatic Impairment1 trial

Hepatic Impairment Study for Lorlatinib in Cancer Patients

Terminated· Pfizer logo

Pfizer·Phase 1·NCT03726333·1 enrolled

Advanced Solid Tumors1 trial

PF-07284892 in Participants With Advanced Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04800822·53 enrolled

Neuroblastoma1 trial

Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Terminated· Pfizer logo

Pfizer··NCT04753658·15 enrolled

Tyrosine Kinase Inhibitor1 trial

Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.

Completed· Pfizer logo

Pfizer··NCT04647110·549 enrolled

Advanced1 trial

Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients

Recruiting·SSichuan Cancer Hospital and Research Institute··NCT06361589·200 enrolled

Metastatic NSCLC1 trial

Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment

Completed·FFundación GECP··NCT05167500·118 enrolled

Leptomeningeal Metastases1 trial

Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases

Not yet recruiting·GGuangdong Association of Clinical Trials·Phase 4·NCT06282874·50 enrolled

Renal Impairment1 trial

Lorlatinib Renal Impairment Study

Completed· Pfizer logo

Pfizer·Phase 1·NCT03542305·29 enrolled

Lung Adenocarcinoma1 trial

Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma

Not yet recruiting·GGuangdong Association of Clinical Trials·Phase 3·NCT06858410·36 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Real-world Study1 trial

Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC

Not yet recruiting·PPeking University Cancer Hospital & Institute··NCT06690541·100 enrolled

Single Dose1 trial

Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT03961997·16 enrolled

Advanced Non-Small Cell Lung Cancer1 trial

Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07415005·30 enrolled

Non-Small-Cell Lung1 trial

LONGITUDINAL REAL-WORLD STUDY OF FIRST-LINE (1L) LORLATINIB IN THE UNITED STATES: PERFORMANCE STATUS AND TREATMENT PATTERNS

Active, not recruiting· Pfizer logo

Pfizer··NCT07567352·200 enrolled

Ganglioneuroblastoma1 trial

A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)

Recruiting·CChildren's Oncology Group·Phase 3·NCT03126916·750 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A RETROSPECTIVE STUDY TO EVALUATE THE REAL-WORLD EFFECTIVENESS OF LORLATINIB AMONG ROS1-POSITIVE NSCLC PATIENTS

Completed· Pfizer logo

Pfizer··NCT06678555·22 enrolled

High Grade Glioma1 trial

A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion

Recruiting·NNationwide Children's Hospital·Phase 1·NCT06333899·15 enrolled

Unspecified1 trial

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 2, 2018

LORBRENA

NDA NDA210868

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Lorlatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lorlatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lorlatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210868). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lorbrena. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: ALK Tyrosine Kinase Receptor Inhibitor; EML4-ALK Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[5]

Patent Cliff

Mar 5, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8680111Mar 5, 2033

10420749Jul 27, 2036

11020376Jul 27, 2036

11299500Oct 4, 2038

Lorbrena

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer15 trials

Lorlatinib8 trials

Non-Small Cell Lung Carcinoma4 trials

Lung Cancer3 trials

Trial2 trials

Small Cell Lung Cancer2 trials

Metastasis2 trials

ALK Positive2 trials

Lymphoma1 trial

Hepatic Impairment1 trial

Advanced Solid Tumors1 trial

Neuroblastoma1 trial

Tyrosine Kinase Inhibitor1 trial

Advanced1 trial

Metastatic NSCLC1 trial

Leptomeningeal Metastases1 trial

Renal Impairment1 trial

Lung Adenocarcinoma1 trial

Erectile Dysfunction1 trial

Real-world Study1 trial

Single Dose1 trial

Advanced Non-Small Cell Lung Cancer1 trial

Non-Small-Cell Lung1 trial

Ganglioneuroblastoma1 trial

Carcinoma, Non-Small-Cell Lung1 trial

High Grade Glioma1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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