Necitumumab
Also known as Portrazza
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
Approved
BLA125547,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ELI LILLY & Co LLY Source: Company record for ELI LILLY & Co (opens in a new tab)
- Indication
- Non Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- BLA 125547 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 125547 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 2 Nov 20092 linked trials
- Filed Completed
- Approved Current stageFirst approval 24 Nov 2015
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Necitumumab. Editors add each one with its source.
Filed application
No filed application is on record for Necitumumab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Necitumumab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT00981058ClinicalTrials.gov record for NCT00981058 (opens in a new tab)SQUIRE | First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin | Phase 3 | Completed | 1,093 (actual) | 17 Jun 2013 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT00981058 (opens in a new tab) |
Posted results on ClinicalTrials.gov for SQUIRE
Serious adverse events (Baseline Up To 156 Months): Necitumumab + Gemcitabine + Cisplatin 262 of 538; Gemcitabine + Cisplatin 208 of 541 Source: ClinicalTrials.gov results for NCT00981058 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing SQUIRE (5), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT00982111ClinicalTrials.gov record for NCT00982111 (opens in a new tab)INSPIRE | First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin | Phase 3 | Completed | 633 (actual) | 14 Nov 2012 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT00982111 (opens in a new tab) |
Posted results on ClinicalTrials.gov for INSPIRE
Serious adverse events: Necitumumab+Pemetrexed+Cisplatin 158 of 304; Pemetrexed+Cisplatin 130 of 312 Source: ClinicalTrials.gov results for NCT00982111 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing INSPIRE (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| BLA125547Action letter for BLA125547 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Withdrawn
Portrazza (EMEA/H/C/003886)
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- Marketing authorisation holder
- Eli Lilly Nederland B.V.
- Active substance (INN)
- necitumumab
- ATC code
- L01
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Portrazza (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 125547 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT00981058 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT00982111 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA BLA125547 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.