Drugs / Necitumumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell squamous lung carcinoma 2 milestones | |||||
| Filed | EU (EMA) | — | non-small cell squamous lung carcinoma | 2015-01-30 | “completed its rolling FDA submission and the European submission for necitumumab in combination with gemcitabine and cisplatin” lilly.com ↗ |
| Filed | US (FDA) | — | non-small cell squamous lung carcinoma | 2015-01-30 | “completed its rolling FDA submission and the European submission for necitumumab in combination with gemcitabine and cisplatin” lilly.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Portrazza | — | 2016-02-15 | europa.eu ↗ |
| Approved | US (FDA) | PORTRAZZA | — | 2015-11-24 | fda.gov ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials · 1 missed | ||||||
| Phase 1 | NCT03360734 | Nov 2017 → May 2020 | cancer | Glycotope GmbH | Completed | No outcome recorded |
| Phase 1 | NCT03054038 | Jul 2017 → Mar 2022 | non-small cell lung carcinoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02789345 | Oct 2016 → Oct 2017 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02496663 | May 2016 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02451930 | Sep 2015 → Jan 2017 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | Missed primary |
| Phase 1 | NCT02411591 | Jun 2015 → Jun 2017 | metastatic neoplasm, non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01088464 | Jan 2010 → Feb 2012 | neoplasm | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00801177 | Nov 2004 → Feb 2007 | cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/23 trials · 1 met primary | ||||||
| Phase 1/2 | NCT04285671 | Jan 2021 → Dec 2026 expected | non-small cell lung carcinoma | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03387111 | Jan 2018 → Apr 2019 | squamous cell carcinoma | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT01763788 | May 2013 → Jun 2017 | non-small cell squamous lung carcinoma | Eli Lilly and Company | Completed | Met primary |
| Phase 210 trials | ||||||
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03574818 | May → Oct 2018 | squamous cell lung carcinoma | Montefiore Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02941601 | Nov 2016 → Dec 2017 | non-small cell squamous lung carcinoma | Eli Lilly and Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02392507 | Oct 2015 → Jan 2018 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT02443337 | Jul 2015 → Sep 2017 | non-small cell lung carcinoma | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 2 | NCT01788566 | Mar 2013 → Aug 2014 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01769391 | Jan 2013 → Apr 2015 | non-small cell squamous lung carcinoma | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01606748 | Aug 2012 → Jun 2013 | cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01624467 | Aug 2012 → May 2014 | cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00835185 | Aug 2007 → Jan 2010 | colorectal cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT00981058 | Jan 2010 → Jun 2013 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00982111 | Nov 2009 → Nov 2012 | non-small cell lung carcinoma | Eli Lilly and Company | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2015-11-24 | Eli Lilly and Company | Regulatory FDA Approves Portrazza™ (necitumumab) for Specific Type of Lung Cancer lilly.com ↗ |
| 2014-05-14 | Eli Lilly and Company | Results Lilly's Necitumumab Improves Overall Survival In Largest Ever Phase III Study In First-Line Treatment Of Stage IV Squamous Non-Small Cell Lung Cancer lilly.com ↗ |
| 2013-08-13 | Eli Lilly and Company | Results Lilly Announces Phase III Necitumumab Study Meets Primary Endpoint of Overall Survival lilly.com ↗ |
| 2011-02-02 | Bristol-Myers Squibb | Results Lilly, Bristol-Myers Squibb Stop Enrollment in One of Two Phase III Lung Cancer Trials of Necitumumab bms.com ↗
Eli Lilly and Company (NYSE: LLY) and Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have stopped enrollment in one of their two global Phase III studies evaluating necitumumab, an investigational anti-cancer agent, as a first-line treatment for advanced non-small cell lung cancer (NSCLC). |
| 2011-02-02 | Eli Lilly and Company | Results Lilly, Bristol-Myers Squibb Stop Enrollment in One of Two Phase III Lung Cancer Trials of Necitumumab lilly.com ↗
The decision to stop enrollment followed an independent Data Monitoring Committee (DMC) recommendation that no new or recently enrolled patients continue treatment in the trial because of safety concerns related to thromboembolism (blood clots) in the experimental arm of the study. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-11-24 | Eli Lilly and Company | FDA Approves Portrazza™ (necitumumab) for Specific Type of Lung Cancer lilly.com ↗ |
| 2015-07-09 | Eli Lilly and Company | Lilly Statement on FDA Advisory Committee Review of Necitumumab lilly.com ↗ |
| 2014-05-14 | Eli Lilly and Company | Lilly's Necitumumab Improves Overall Survival In Largest Ever Phase III Study In First-Line Treatment Of Stage IV Squamous Non-Small Cell Lung Cancer lilly.com ↗ |
| 2013-08-13 | Eli Lilly and Company | Lilly Announces Phase III Necitumumab Study Meets Primary Endpoint of Overall Survival lilly.com ↗ |
| 2011-02-02 | Bristol-Myers Squibb | Lilly, Bristol-Myers Squibb Stop Enrollment in One of Two Phase III Lung Cancer Trials of Necitumumab bms.com ↗ |
| 2011-02-02 | Eli Lilly and Company | Lilly, Bristol-Myers Squibb Stop Enrollment in One of Two Phase III Lung Cancer Trials of Necitumumab lilly.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Necitumumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04285671 ↗ |
| Known as | 11F8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743047 ↗ |
| Known as | IMC-11F8 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00835185 ↗ |
| Known as | Portrazza | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743047 ↗ |
| Action | Inhibit | “competitively inhibits ligand binding” PMID 25701171 ↗ Feb 2015 |
| Modality | Monoclonal antibody | “fully human anti-EGFR monoclonal antibody” NCT00801177 ↗ |
| Route | Intravenous | “Cycle of therapy administered intravenously, once a week for 6 weeks, for a total of six doses per cycle.” NCT00801177 ↗ |
| Target | EGFR | “anti-EGFR” NCT00801177 ↗ |