PORTRAZZA
Portrazza (necitumumab) is an epidermal growth factor receptor (EGFR) antagonist indicated for the first-line treatment of patients with metastatic squamous non-small cell lung cancer. It is administered in combination with the chemotherapy agents gemcitabine and cisplatin. The use of this drug is specifically limited to the squamous subtype and is not indicated for the treatment of non-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.
Details
- Status
- Prescription
- First Approved
- 2015-11-24
- 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 Competitors
Pro10 other drugs also target EGFR. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (EGFR). Earlier expiry dates signal biosimilar/generic opportunities.
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
ProIndications & Usage
FDA Label (PDF)PORTRAZZA™ is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer. 1.1 Squamous Non-Small Cell Lung Cancer (NSCLC) PORTRAZZA™ is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. 1.2 Limitation of Use PORTRAZZA is not indicated for treatment of non-...
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.