necitumumab
Trade name: portrazza
mAbapprovedOrphan Drug FDAFast Track FDA
Approved
Nov 24, 2015
Necitumumab (INN) is a recombinant human IgG1 monoclonal antibody used as an antineoplastic, which is manufactured by Eli Lilly. It binds to the epidermal growth factor receptor (EGFR). The US FDA approved necitumumab under the brand name Portrazza for use with gemcitabine and cisplatin in previously untreated metastatic squamous non-small-cell lung carcinoma (NSCLC). It was counterproductive in non-squamous non-small-cell lung carcinoma. — Wikipedia
Clinical trial activity
22 trials · 25 clinical orgs · 1 marketing orgs
Phase 1
10
Phase 2
15
Phase 3
2
Phase 4
0
Earliest trial started Nov 1, 2004 (NCT00801177)
Timeline
2000s
Indications
Approved for
Mechanism of action
EGFR inhibitor
Approval history
- approvedFast trackNov 24, 2015
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaNecitumumab ↗
- NCATS2BT4C47RUI ↗
- ChEMBLCHEMBL1743047 ↗
Also known as
- 11f8
- imc-11f8
- imc-11f8
- imc-11f8
- imc-11f8 monoclonal antibody
- necitumumab
- necitumumab
- necitumumab
- necitumumab
- necitumumab
- necitumumab
- necitumumab
- necitumumab
- necitumumab
- portrazza
- portrazza
- portrazza
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04285671 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2020 | Eli Lilly, Genentech, University of California, Los Angeles |
| NCT03944772 | Phase 2 | Jun 28, 2019 | AstraZeneca, Memorial Sloan-Kettering Cancer Center |
| NCT03574818 | Phase 2 | Feb 26, 2018 | Eli Lilly, Yeshiva University |
| NCT03387111 | Phase 1/Phase 2 (Phase 2) | Jan 13, 2018 | NantWorks |
| NCT03054038 | Phase 1 | Jun 15, 2017 | National Cancer Institute (NCI), Vanderbilt University |
| NCT02941601 | Phase 2 | Nov 1, 2016 | Eli Lilly |
| NCT02789345 | Phase 1 | Oct 24, 2016 | AstraZeneca, Eli Lilly |
| NCT02496663 | Phase 1 | Mar 24, 2016 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT02392507 | Phase 2 | Oct 1, 2015 | Celgene, Eli Lilly |
| NCT02451930 | Phase 1 | Sep 1, 2015 | Eli Lilly, Merck |
| NCT02443337 | Phase 2 | Jul 1, 2015 | Eli Lilly, SCRI Development Innovations |
| NCT02411591 | Phase 1 | Jun 1, 2015 | Eli Lilly |
| NCT01763788 | Phase 1/Phase 2 (Phase 2) | May 1, 2013 | Eli Lilly |
| NCT01788566 | Phase 2 | Mar 1, 2013 | Eli Lilly |
| NCT01769391 | Phase 2 | Jan 1, 2013 | Eli Lilly |
| NCT01606748 | Phase 2 | Aug 1, 2012 | Eli Lilly |
| NCT01624467 | Phase 2 | Aug 1, 2012 | Eli Lilly |
| NCT00981058 | Phase 3 | Jan 1, 2010 | Eli Lilly, ICON, Intertek, LabCorp, Medidata Solutions, Pacific Biomarkers, Parexel, PPD, Sysmex Inostics GmbH, Thermo Fisher Scientific, University of Colorado, Denver |
| NCT01088464 | Phase 1 | Jan 1, 2010 | Eli Lilly, Parexel |
| NCT00982111 | Phase 3 | Nov 1, 2009 | Eli Lilly, Intertek, IQVIA, LabCorp, Medidata Solutions, Pacific Biomarkers, Parexel, PPD, Sysmex Inostics GmbH, Thermo Fisher Scientific, University of Colorado, Denver |
Showing 20 of 22 trials
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Organizations
Research & Development (25)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eli Lilly | For profit | 17 | 15 | 3 | 2007 |
| Parexel | For profit | 3 | 0 | 2 | 2009 |
| AstraZeneca | For profit | 2 | 1 | 2 | 2016 |
| Intertek | For profit | 2 | 0 | 1 | 2009 |
| LabCorp | For profit | 2 | 0 | 1 | 2009 |
| Medidata Solutions | For profit | 2 | 0 | 1 | 2009 |
| National Cancer Institute (NCI) | Government | 2 | 1 | 1 | 2016 |
| Pacific Biomarkers | For profit | 2 | 0 | 1 | 2009 |
| PPD | For profit | 2 | 0 | 1 | 2009 |
| Sysmex Inostics GmbH | For profit | 2 | 0 | 1 | 2009 |
| Thermo Fisher Scientific | For profit | 2 | 0 | 1 | 2009 |
| University of Colorado, Denver | Academic/Hospital | 2 | 0 | 1 | 2009 |
| Celgene | For profit | 1 | 0 | 1 | 2015 |
| City of Hope National Medical Center | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Genentech | For profit | 1 | 0 | 1 | 2020 |
| ICON | For profit | 1 | 0 | 1 | 2010 |
| Imclone | For profit | 1 | 1 | 1 | 2004 |
| IQVIA | For profit | 1 | 0 | 1 | 2009 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Merck | For profit | 1 | 0 | 1 | 2015 |
25 organizations
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