Drugs / Olaratumab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed soft tissue sarcoma 2 milestones | |||||
| Filed | EU (EMA) | — | soft tissue sarcoma | 2016-04-26 | “Lilly also submitted olaratumab to the European Medicines Agency (EMA) in the first quarter of 2016” lilly.com ↗ “The company submitted olaratumab to both the FDA and the EMA for soft tissue sarcoma.” lilly.com ↗ |
| Filed | US (FDA) | — | soft tissue sarcoma | 2016-04-26 | “The company submitted olaratumab to both the FDA and the EMA for soft tissue sarcoma.” lilly.com ↗ |
| Withdrawn Indication not stated 3 milestones | |||||
| Withdrawn | EU (EMA) | Lartruvo | — | 2019-07-22 | europa.eu ↗ |
| Approved · conditional | EU (EMA) | Lartruvo | — | 2016-11-09 | europa.eu ↗ |
| Approved | US (FDA) | LARTRUVO | — | 2016-10-19 | fda.gov ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials · 1 met primary | ||||||
| Phase 1 | NCT03437070 | Jun 2019 → Jun 2021 | leiomyosarcoma | University of Miami | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03985722 | Sep 2018 → Feb 2021 | soft tissue sarcoma | Spanish Group for Research in Sarcomas | Unknown | No outcome recorded |
| Phase 1 | NCT03126591 | Jul 2017 → May 2021 | soft tissue sarcoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03056599 | Dec 2016 → Jul 2021 | soft tissue sarcoma | Presage Biosciences | Completed | Met primary |
| Phase 1 | NCT02783599 | Oct 2016 → Jul 2018 | soft tissue sarcoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02677116 | Aug 2016 → Oct 2018 | metastatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02377752 | Mar 2015 → Aug 2018 | neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02326025 | Jan → May 2015 | soft tissue sarcoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01199822 | Sep 2010 → Jan 2012 | cancer, metastatic neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00768391 | Dec 2006 → Mar 2009 | cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/23 trials · 2 missed | ||||||
| Phase 1/2 | NCT03086369 | Jun 2017 → Jan 2021 | malignant pancreatic neoplasm | Eli Lilly and Company | Completed | Missed primary |
| Phase 1/2 | NCT02659020 | Mar 2016 → Jul 2020 | soft tissue sarcoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 1/2 | NCT01185964 | Oct 2010 → Aug 2014 | soft tissue sarcoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 26 trials · 2 missed | ||||||
| Phase 2 | NCT03698227 | Nov 2018 → Jun 2020 | soft tissue sarcoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Terminated | No outcome recorded |
| Phase 2 | NCT01316263 | Aug 2011 → May 2012 | gastrointestinal stromal tumor | Eli Lilly and Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01204710 | Oct 2010 → Sep 2012 | prostate cancer | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00895180 | Jul 2010 → Jun 2012 | adult glioblastoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 2 | NCT00918203 | Jan 2010 → Aug 2013 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00913835 | Jun 2009 → Oct 2011 | ovarian neoplasm | Eli Lilly and Company | Completed | Missed primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT02451943 | Sep 2015 → Dec 2018 | soft tissue sarcoma | Eli Lilly and Company | Completed | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT03994627 | — | soft tissue sarcoma | Eli Lilly and Company | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2019-05-15 | Eli Lilly and Company | Results Data Presentations at ASCO 2019 Highlight Lilly's Targeted Approach to Developing Treatments for Patients Living with Cancer lilly.com ↗
Unfortunately, this study did not confirm a survival benefit seen in a prior Phase 2 trial. |
| 2019-04-25 | Eli Lilly and Company | Regulatory Lilly to Establish an Access Program for Patients as it Prepares to Withdraw Lartruvo from the Global Market lilly.com ↗ |
| 2019-01-18 | Eli Lilly and Company | Results Lilly Reports Results of Phase 3 Soft Tissue Sarcoma Study of LARTRUVO® lilly.com ↗
Specifically, the study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population. |
| 2016-10-19 | Eli Lilly and Company | Regulatory FDA Approves Lilly's LARTRUVO™ (olaratumab) in Combination with Doxorubicin for Soft Tissue Sarcoma lilly.com ↗
LARTRUVO's indication is approved under Accelerated Approval, and is based on data from the Phase 2 portion of the pivotal JGDG trial. |
| 2016-09-16 | Eli Lilly and Company | Regulatory CHMP Recommends Approval of Lilly's Olaratumab, in Combination with Doxorubicin, for Advanced Soft Tissue Sarcoma lilly.com ↗
The CHMP positive opinion is now referred for final action to the European Commission, which grants marketing authorization in the EU. |
| 2016-06-09 | Eli Lilly and Company | Results Data in The Lancet Show Olaratumab Plus Doxorubicin Offered 11.8-Month Increase in Overall Survival in Patients with Advanced Soft Tissue Sarcoma, as Reported by Lilly and Memorial Sloan Kettering Researchers lilly.com ↗
The study met its primary endpoint of progression-free survival (PFS) and showed a statistically significant improvement in overall survival (OS), a key secondary endpoint. |
| 2016-05-04 | Eli Lilly and Company | Regulatory FDA Grants Priority Review for Lilly's Olaratumab, an Investigational Medicine for Advanced Soft Tissue Sarcoma lilly.com ↗
"We are encouraged that the FDA has granted Priority Review for olaratumab as a potential treatment for advanced soft tissue sarcoma," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. |
All press releases naming this drug 8 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Olaratumab | “A Study of Olaratumab (IMC-3G3) in Prostate Cancer” NCT01204710 ↗ |
| Known as | IMC-3G3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00768391 ↗ |
| Known as | Lartruvo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743049 ↗ |
| Known as | LY3012207 | “A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer” NCT03086369 ↗ |
| Action | Inhibit | “Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal antibody IMC-3G3 (Olaratumab), can block tumor growth.” NCT00895180 ↗ |
| Modality | Monoclonal antibody | “anti-PDGFRα monoclonal antibody IMC-3G3” NCT00768391 ↗ |
| Route | Intravenous | “All patients will receive intravenous infusions of IMC-3G3” NCT00768391 ↗ |
| Target | PDGFRA | “Human Anti-PDGFRα Monoclonal Antibody” NCT00918203 ↗ |