Data updated: May 26, 2026
LARTRUVO (olaratumab)
Trial Activity: Declining
Orphan Drug Breakthrough Therapy Priority Review Accelerated Approval
Oncology
Approved 2016-10-19
Development Insights
Eli Lilly and Company conducting 15 trials (83%)
14 indications explored (Broad Platform)
→ soft tissue sarcoma (5 trials)
→ sarcoma, soft tissue (2 trials)
→ metastatic pancreatic cancer (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
9
Years on Market
Details
- Status
- Prescription
- First Approved
- 2016-10-19
- Patent Cliff
- 2020
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LARTRUVO Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2016 to 2019
Jul 2019 SUPPL
Mfg · Manufacturing (CMC)
Aug 2018 SUPPL
Mfg · Manufacturing (CMC)
What LARTRUVO Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
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Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02451943 ANNOUNCE results posted | 15677 I5B-MC-JGDJ, 2015-000134-30 | Ph 3 | completed | A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma |
| NCT03126591 results posted | 15847 I5B-MC-JGDQ, 2016-001949-19 | Ph 1 | completed | A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma |
| NCT03086369 results posted | 15844 I5B-MC-JGDP, 2016-001099-31 | Ph 1, Ph 2 | completed | A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer |
| NCT02659020 ANNOUNCE 2 results posted | 15839 I5B-MC-JGDL, 2015-001316-34 | Ph 1, Ph 2 | completed | A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma |
| NCT02377752 results posted | 15678 I5B-JE-JGDK | Ph 1 | completed | A Study of Olaratumab in Japanese Participants With Advanced Cancer |
| NCT03283696 results posted | 16430 I5B-MC-JGDR, 2016-004287-19 | Ph 1 | completed | A Study of Olaratumab (LY3012207), Doxorubicin, and Ifosfamide in Participants With Advanced or Metastatic Soft Tissue Sarcoma |
| NCT03698227 | OlaReDo_GISG-17 | Ph 2 | terminated | OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients |
| NCT02677116 results posted | 15841 I5B-MC-JGDN | Ph 1 | completed | A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer |
| NCT02326025 results posted | 15676 I5B-EW-JGDI | Ph 1 | completed | A Study of Olaratumab and Doxorubicin in Participants With Advanced Soft Tissue Sarcoma |
| NCT00913835 results posted | 13899 2009-009035-30, CP15-0802 | Ph 2 | completed | A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer |
| NCT01204710 results posted | 13938 I5B-IE-JGDD, CP15-0805 | Ph 2 | completed | A Study of Olaratumab (IMC-3G3) in Prostate Cancer |
| NCT02783599 results posted | 15840 I5B-MC-JGDM, 2015-005018-31 | Ph 1 | completed | A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma |
| NCT03437070 | 20170991 | Ph 1 | withdrawn | Trabectedin, Doxorubicin and Olaratumab in Patients With Metastatic or Recurrent Leiomyosarcoma |
| NCT00918203 results posted | 13900 CP15-0804, I5B-IE-JGDB | Ph 2 | completed | A Study of Paclitaxel/Carboplatin With or Without Olaratumab (IMC-3G3) in Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) |
| NCT00895180 results posted | ABTC-0901 CDR0000641230 U01CA137443, ABTC-0901 | Ph 2 | completed | Ramucirumab or Anti-PDGFR Alpha Monoclonal Antibody IMC-3G3 in Treating Patients With Recurrent Glioblastoma Multiforme |
| NCT01199822 results posted | 13940 CP15-0907, I5B-IE-JGDF | Ph 1 | completed | Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors |
| NCT01185964 results posted | 14055 I5B-IE-JGDG, CP15-0806 | Ph 1, Ph 2 | completed | A Study of Olaratumab in Soft Tissue Sarcoma |
| NCT01316263 results posted | 14244 CP15-1008, I5B-IE-JGDH | Ph 2 | terminated | A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LARTRUVO FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment