Drugs / Lorlatinib
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LORBRENA | — | 2021-03-03 | fda.gov ↗ |
| Filed | US (FDA) | LORBRENA | first-line non-small cell lung cancer | 2020-12-28 | “FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib) as a first-line treatment” pfizer.com ↗ |
| Approved | EU (EMA) | Lorviqua | — | 2019-05-06 | europa.eu ↗ |
| Approved | US (FDA) | LORBRENA | — | 2018-11-02 | fda.gov ↗ |
| Filed | EU (EMA) | — | ALK-positive metastatic NSCLC | 2018-02-12 | “The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib.” pfizer.com ↗ |
| Filed | US (FDA) | — | ALK-positive metastatic NSCLC | 2018-02-12 | “today announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib.” pfizer.com ↗ |
| Filed | Japan (PMDA) | — | ALK-positive metastatic NSCLC | 2018-02-12 | “The European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency have also accepted marketing applications for the use of lorlatinib.” pfizer.com ↗ |
Trials 48
| 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 · 1 met primary | ||||||
| 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 Stop: Business |
| 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 Stop: Enrollment |
| Phase 1 | NCT03726333 | Jan 2020 → Jul 2021 | cancer of unknown primary site | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| 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 | Met primary |
| 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 Stop: Business |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 | Mixed |
| Phase 32 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 → Oct 2029 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 |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT07617337 Background | Jul 2026 → Aug 2030 expected | non-small cell lung carcinoma | Chugai Pharmaceutical | Recruiting | No outcome recorded |
| 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 |
| — | NCT03127618 Background | — | — | Pfizer | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Chugai Pharmaceutical | Regulatory Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Lorlatinib for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer chugai-pharm.co.jp ↗
This approval enables the detection of ALK fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use lorlatinib for ALK fusion gene-positive NSCLC. |
| 2026-05-29 | Pfizer | Results 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 ↗
At seven years, patients treated with LORBRENA had a 55% likelihood of remaining alive without disease progression (95% Confidence Interval [CI], 46-63) compared to 3% (95% CI, 1-8) in the XALKORI treatment arm. |
| 2026-04-21 | Pfizer | Results Pfizer Showcases Oncology Innovation and Next-Generation Pipeline at ASCO 2026 pfizer.com ↗
Seven-year update from the pivotal Phase 3 CROWN study further supports LORBRENA ® (lorlatinib) as a guideline-recommended first-line treatment for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). |
| 2024-05-31 | Pfizer | Results Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression pfizer.com ↗
Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm. |
| 2022-01-28 | Pfizer | Regulatory European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) granted marketing authorization for LORVIQUA ® (lorlatinib, available in the U.S. under the brand name LORBRENA ® ) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. |
| 2021-12-17 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for LORVIQUA® (lorlatinib) as First-Line Treatment for ALK-Positive Advanced Lung Cancer pfizer.com ↗
This positive CHMP opinion solidifies LORVIQUA as an effective first-line treatment option for those living with ALK-positive advanced non-small cell lung cancer in Europe. |
| 2021-03-03 | Pfizer | Regulatory U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer pfizer.com ↗
The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA ® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). |
| 2020-12-28 | Pfizer | Regulatory 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 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 ↗
At a planned interim analysis, LORBRENA treatment resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) according to blinded independent central review (BICR), the primary endpoint, compared to XALKORI |
| 2020-08-05 | Pfizer | Results LORBRENA® (lorlatinib) Significantly Improves Progression-Free Survival in First-Line ALK-Positive Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the Phase 3 CROWN study of LORBRENA ® (lorlatinib) in people with previously untreated advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) met its primary endpoint by demonstrating significantly improved progression-free survival (PFS), as compared to XALKORI ® (crizotinib). |
| 2019-05-07 | Pfizer | Regulatory European Commission Approves LORVIQUA® (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) granted conditional marketing authorization for LORVIQUA ® (lorlatinib, available in the U.S., Canada and Japan under the brand name LORBRENA ® ), as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI. |
| 2019-03-01 | Pfizer | Regulatory 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 ↗
This CHMP opinion represents a step forward in bringing LORVIQUA to patients in Europe living with advanced ALK-positive non-small cell lung cancer who have limited treatment options. |
| 2018-11-02 | Pfizer | Regulatory U.S. FDA Approves LORBRENA® (lorlatinib) for Previously-Treated ALK-Positive Metastatic NSCLC pfizer.com ↗
This indication is approved under accelerated approval based on tumor response rate and duration of response. |
| 2018-02-12 | Pfizer | Regulatory U.S., EU and Japan Health Authorities Accept Regulatory Submissions for Review of Pfizer’s Third-Generation ALK Inhibitor Lorlatinib pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the company’s New Drug Application for lorlatinib. |
| 2017-10-16 | Pfizer | Results 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 ↗
Pfizer Inc. (NYSE:PFE) today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated. |
| 2017-04-27 | Pfizer | Regulatory 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 ↗
lorlatinib, was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) |
| 2016-06-06 | Pfizer | Results Pfizer Presents Promising Data from Next Generation ALK/ROS1 Inhibitor in Advanced Non-Small Cell Lung Cancer pfizer.com ↗
Among patients with ALK-positive metastatic NSCLC, the overall response rate (ORR) with lorlatinib was 46 percent, with three patients achieving complete responses and 16 patients achieving a partial response (95% CI: 31-63). |
All press releases naming this drug 17 releases
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 |