Drugs / Lorlatinib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LORBRENA | — | 2021-03-03 | fda.gov ↗ |
| Approved | EU (EMA) | Lorviqua | — | 2019-05-06 | europa.eu ↗ |
| Approved | US (FDA) | LORBRENA | — | 2018-11-02 | fda.gov ↗ |
Trials 48 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06333899 | Aug 2025 → Jul 2029 expected | anaplastic astrocytoma, diffuse midline glioma, H3 K27-altered, glioblastoma, grade III glioma +1 | Nationwide Children's Hospital | Recruiting | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT05224609 | Apr 2022 → Aug 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04800822 | Mar 2021 → Jun 2024 | neoplasm | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT04541407 | Oct 2020 → Apr 2022 | non-small cell lung carcinoma | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03726333 | Jan 2020 → Jul 2021 | cancer of unknown primary site | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT03961997 | Aug → Dec 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03542305 | Aug 2018 → Feb 2020 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03107988 | Sep 2017 → Aug 2024 | neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Completed | No outcome recorded |
| Phase 1 | NCT03184168 | Jul → Aug 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02838264 | Aug 2016 → Mar 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02804399 | Jul → Oct 2016 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02569554 | Dec 2015 → Apr 2016 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02564562 | Oct → Nov 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06007937 | Aug 2023 → Aug 2028 expected | metastatic malignant neoplasm, non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04292119 | May 2020 → Dec 2022 | non-small cell lung carcinoma, refractory malignant neoplasm | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT02584634 | Dec 2015 → Feb 2021 | non-small cell lung carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT01970865 | Jan 2014 → Mar 2017 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 221 trials | ||||||
| Phase 2 | NCT07415005 | Apr 2026 → Jul 2028 expected | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07083687 | Aug 2025 → Jan 2027 expected | non-small cell lung carcinoma | Hunan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06682884 | Nov 2024 → Apr 2026 overdue | non-small cell lung carcinoma | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06378892 | Mar 2024 → May 2028 expected | non-small cell lung carcinoma | Centro di Riferimento Oncologico - Aviano | Recruiting | No outcome recorded |
| Phase 2 | NCT05948462 | Nov 2023 → Mar 2025 | non-small cell lung carcinoma | SCRI Development Innovations, LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT06092086 | Aug 2023 → Aug 2025 overdue | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Recruiting | No outcome recorded |
| Phase 2 | NCT05740943 | Mar 2023 → Dec 2025 overdue | non-small cell lung carcinoma | Guangdong Provincial People's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05297890 | May 2022 → Dec 2023 overdue | — | CStone Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT05014464 | Nov 2021 → Jun 2026 overdue | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04621188 | Mar 2021 → Feb 2025 overdue | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04127110 | Nov 2020 → Jul 2024 overdue | non-small cell lung carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04111705 | Aug 2020 → Aug 2022 | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Completed | No outcome recorded |
| Phase 2 | NCT04322890 | Apr 2020 → Dec 2026 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03505554 | Sep 2019 → Dec 2025 | ALK-positive anaplastic large cell lymphoma | University of Milano Bicocca | Completed | No outcome recorded |
| Phase 2 | NCT03737994 | Jul 2019 → Jul 2021 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 2 | NCT03612154 | May 2019 → Dec 2022 | non-small cell lung carcinoma | National Cancer Center, Korea | Unknown | No outcome recorded |
| Phase 2 | NCT03909971 | Apr 2019 → Aug 2020 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03439215 | Jun 2017 → Jun 2022 | non-small cell lung carcinoma | Fondazione Ricerca Traslazionale | Unknown | No outcome recorded |
| Phase 2 | NCT02927340 | Oct 2016 → Jan 2022 | non-small cell lung carcinoma | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03126916 | May 2018 → Sep 2030 expected | neuroblastoma, nodular ganglioneuroblastoma | Children's Oncology Group | Recruiting | No outcome recorded |
| Phase 3 | NCT03052608 | Apr 2017 → Mar 2020 overdue | non-small cell lung carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT06893354 | May 2025 → Jul 2027 expected | non-small cell lung carcinoma | The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06282874 | Aug 2024 → Apr 2026 overdue | metastatic malignant neoplasm in the brain, neoplastic meningitis, non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05144997 | Dec 2021 → Dec 2026 expected | non-small cell lung carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04362072 | Sep 2020 → May 2024 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT04541706 | Aug 2020 → Jul 2022 | non-small cell lung carcinoma | Pfizer | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06487078 | Jan 2025 → Nov 2028 expected | non-small cell lung carcinoma | Pfizer | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03178071 | — | lung cancer | Pfizer | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07617337 Background | Jul 2026 → Aug 2030 expected | non-small cell lung carcinoma | Chugai Pharmaceutical | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06858410 Comparator | Mar 2025 → Mar 2030 expected | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03127618 Background | — | — | Pfizer | Approved for marketing | No outcome recorded |
Press releases naming this drug 14 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-29 | Pfizer | Seven-Year Analysis from Pfizer’s LORBRENA CROWN Trial Shows Longest Progression-Free Survival Reported to Date in Advanced Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2024-05-31 | Pfizer | Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression pfizer.com ↗ |
| 2022-01-28 | Pfizer | European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer pfizer.com ↗ |
| 2021-12-17 | Pfizer | Pfizer Receives Positive CHMP Opinion for LORVIQUA® (lorlatinib) as First-Line Treatment for ALK-Positive Advanced Lung Cancer pfizer.com ↗ |
| 2021-03-03 | Pfizer | U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer pfizer.com ↗ |
| 2020-12-28 | Pfizer | LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA pfizer.com ↗ |
| 2020-11-19 | Pfizer | Results from Phase 3 CROWN Trial of Pfizer’s LORBRENA® (lorlatinib) in Previously Untreated ALK-Positive Lung Cancer Published in the New England Journal of Medicine pfizer.com ↗ |
| 2020-08-05 | Pfizer | LORBRENA® (lorlatinib) Significantly Improves Progression-Free Survival in First-Line ALK-Positive Lung Cancer pfizer.com ↗ |
| 2019-05-07 | Pfizer | European Commission Approves LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2019-03-01 | Pfizer | Pfizer Receives Positive CHMP Opinion for LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2018-11-02 | Pfizer | U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC pfizer.com ↗ |
| 2018-02-12 | Pfizer | U.S., EU and Japan Health Authorities Accept Regulatory Submissions for Review of Pfizer’s Third-Generation ALK Inhibitor Lorlatinib pfizer.com ↗ |
| 2017-10-16 | Pfizer | Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational ALK-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer pfizer.com ↗ |
| 2017-04-27 | Pfizer | Pfizer’s Next-Generation ALK/ROS1 Inhibitor, Lorlatinib, Granted Breakthrough Therapy Designation from FDA for ALK-Positive Metastatic Non-Small Cell Lung Cancer pfizer.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lorlatinib | “Her tumor did not respond to a second-generation ALK inhibitor, but it did respond to lorlatinib (PF-06463922), a third-generation inhibitor.” PMID 26698910 ↗ Dec 201545“Participants will receive continuous daily PO dosing of lorlatinib 100mg QD.” NCT06092086 ↗ “Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;” NCT04322890 ↗ “Lorlatinib is an oral ALK and ROS1 inhibitor.” NCT04292119 ↗ “Lorlatinib 100mg po qd” NCT05014464 ↗ |
| Known as | [14C]lorlatinib | “Drug: [14C]lorlatinib” NCT03184168 ↗ |
| Known as | Lorbrena | “This arm of the Strata PATH trial will assess the clinical benefit of Lorbrena® (lorlatinib) in ALK and ROS1 gene fusion positive solid tumors, as detected by Strata testing,...” NCT05097599 ↗1“researchers looked at the effects of two medicines called lorlatinib (Lorbrena) and crizotinib (Xalkori) for people with advanced non-small cell lung cancer (NSCLC) who had not...” PMID 39360949 ↗ Oct 2024 |
| Known as | PF-06463922 | “PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF MODAFINIL ON THE PHARMACOKINETICS OF SINGLE DOSE LORLATINIB (PF-06463922) IN...” NCT03961997 ↗8“Her tumor did not respond to a second-generation ALK inhibitor, but it did respond to lorlatinib (PF-06463922), a third-generation inhibitor.” PMID 26698910 ↗ Dec 2015 “LORLATINIB (PF-06463922) MONOTHERAPY” NCT03909971 ↗ “Lorlatinib - PF-06463922” NCT03127618 ↗ |
| Action | Inhibit | “Lorlatinib is a small molecule inhibitor of anaplastic lymphoma kinase (ALK) and c-ROS oncogene 1 (ROS1) tyrosine kinases” PMID 33973232 ↗ Jun 2021 |
| Modality | Small molecule | “Lorlatinib is a small molecule inhibitor of anaplastic lymphoma kinase (ALK) and c-ROS oncogene 1 (ROS1) tyrosine kinases” PMID 33973232 ↗ Jun 2021 |
| Route | Oral | “Single oral dose of 100mg PF-06463922” NCT02564562 ↗ |
| Target | ALK | “Lorlatinib is a small molecule inhibitor of anaplastic lymphoma kinase (ALK) and c-ROS oncogene 1 (ROS1) tyrosine kinases” PMID 33973232 ↗ Jun 2021 |
| Target | ROS1 | “Lorlatinib is a small molecule inhibitor of anaplastic lymphoma kinase (ALK) and c-ROS oncogene 1 (ROS1) tyrosine kinases” PMID 33973232 ↗ Jun 2021 |