PORTRAZZA (necitumumab)
PORTRAZZA is indicated for the treatment of Squamous Non-Small Cell Lung Cancer.
How PORTRAZZA Works
Necitumumab is a recombinant human IgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR), blocking the receptor from binding with its ligands. By inhibiting EGFR activation, the drug interferes with processes correlated to malignant progression, such as angiogenesis and the inhibition of apoptosis. Furthermore, necitumumab induces EGFR internalization and degradation and facilitates antibody-dependent cellular cytotoxicity in cells expressing the receptor.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-11-24
- Patent Cliff
- 2022
- Routes
- INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL
- Dosage Forms
- INJECTABLE
PORTRAZZA Approval History
What PORTRAZZA Treats
1 indicationsPORTRAZZA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Squamous Non-Small Cell Lung Cancer
PORTRAZZA Boxed Warning
CARDIOPULMONARY ARREST and HYPOMAGNESEMIA Cardiopulmonary arrest and/or sudden death occurred in 3.0% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration [see Warnings and Precautions ( 5.1 , 5.2 )] . Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine an...
WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA Cardiopulmonary arrest and/or sudden death occurred in 3.0% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration [see Warnings and Precautions ( 5.1 , 5.2 )] . Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine and cisplatin, and was severe in 20% of patients. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of PORTRAZZA during treatment and for at least 8 weeks following completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate [see Warnings and Precautions ( 5.2 )] . WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA See full prescription information for complete boxed warning Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after PORTRAZZA administration. ( 5.1 , 5.2 ) Hypomagnesemia occurred in 83% of patients receiving PORTRAZZA in combination with gemcitabine and cisplatin, and was severe in 20%. Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of PORTRAZZA during treatment and for at least 8 weeks following completion of PORTRAZZA. Withhold PORTRAZZA for Grade 3 or 4 electrolyte abnormalities. Replete electrolytes as medically appropriate. ( 5.2 )
PORTRAZZA Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
PORTRAZZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PORTRAZZA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PORTRAZZA treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02496663 | NCI-2015-01053 NCI-2015-01053, PHI-77 | Ph 1 | active not recruiting | Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor |
| NCT04285671 | 19-002190 NCI-2020-00677 | Ph 1, Ph 2 | active not recruiting | Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer |
| NCT00981058 SQUIRE results posted | 13909 CP11-0806, I4X-IE-JFCC | Ph 3 | completed | First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin |
| NCT03944772 ORCHARD | D6186C00001 2023-504624-25-00, 2018-003974-29 | Ph 2 | active not recruiting | Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) |
| NCT03387111 results posted | QUILT-3.090 | Ph 1, Ph 2 | terminated | QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed |
| NCT02789345 results posted | 16357 I4T-MC-JVDL, 2015-005296-25 | Ph 1 | completed | A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer |
| NCT03054038 | VICC THO 1684 NCI-2016-01532 | Ph 1 | terminated | Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer |
| NCT00982111 INSPIRE results posted | 13908 2009-012574-12, CP11-0805 | Ph 3 | completed | First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin |
| NCT02443337 results posted | 15799 I6A-MC-CBBE | Ph 2 | terminated | A Study of LY3023414 and Necitumumab in Squamous Lung Cancer |
| NCT02392507 results posted | 15529 I4X-MC-JFCP | Ph 2 | completed | A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC |
| NCT02451930 results posted | 15568 I4X-MC-JFCQ, 2015-001291-22 | Ph 1 | completed | A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC |
| NCT02411591 results posted | 15573 I4X-MC-JFCU | Ph 1 | completed | A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC) |
| NCT01763788 results posted | 14461 I4X-JE-JFCM | Ph 1, Ph 2 | completed | A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) |
| NCT01606748 results posted | 14473 CP11-1115, I4X-IE-JFCJ | Ph 2 | completed | A Drug-Interaction Study of Necitumumab (IMC-11F8) in Combination With Gemcitabine-Cisplatin |
| NCT02941601 | 16535 I4X-MC-JFDA, 2016-002041-31 | Ph 2 | withdrawn | A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) |
| NCT01769391 results posted | 14790 I4X-MC-JFCL, 2012-003214-13 | Ph 2 | completed | A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer |
| NCT01624467 results posted | 14472 CP11-1114, I4X-IE-JFCI | Ph 2 | completed | A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors |
| NCT01788566 results posted | 14789 I4X-MC-JFCK | Ph 2 | completed | A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
PORTRAZZA FDA Label Details
Indications & Usage
FDA Label (PDF)PORTRAZZA is indicated for the treatment of Squamous Non-Small Cell Lung Cancer.
WARNING: CARDIOPULMONARY ARREST and HYPOMAGNESEMIA Cardiopulmonary arrest and/or sudden death occurred in 3.0% of patients treated with PORTRAZZA in combination with gemcitabine and cisplatin. Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive repl...
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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