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Portrazza (NECITUMUMAB)
Portrazza works by blocking the epidermal growth factor receptor (EGFR) protein, which is involved in cancer cell growth and proliferation.
Portrazza (Necitumumab) is a small molecule Epidermal Growth Factor Receptor (EGFR) antagonist developed by Eli Lilly Co. It targets EGFR, a protein involved in cancer cell growth, and is approved for the treatment of non-small cell lung cancer and squamous non-small cell lung cancer. Portrazza was first approved by the FDA in 2015 and remains a patented product. Key safety considerations include its potential to cause infusion reactions, rash, and fatigue. As a targeted therapy, Portrazza works by blocking the EGFR protein, thereby inhibiting cancer cell growth and proliferation.
At a glance
| Generic name | NECITUMUMAB |
|---|---|
| Sponsor | Eli Lilly Co |
| Drug class | Epidermal Growth Factor Receptor Antagonist [EPC] |
| Target | Epidermal growth factor receptor |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2015 |
Mechanism of action
Necitumumab is recombinant human lgG1 monoclonal antibody that binds to the human epidermal growth factor receptor (EGFR) and blocks the binding of EGFR to its ligands. Expression and activation of EGFR has been correlated with malignant progression, induction of angiogenesis, and inhibition of apoptosis. Binding of necitumumab induces EGFR internalization and degradation in vitro. In vitro, binding of necitumumab also led to antibody-dependent cellular cytotoxicity (ADCC) in EGFR-expressing cells.In in vivo studies using xenograft models of human cancer, including non-small cell lung carcinoma, administration of necitumumab to implanted mice resulted in increased antitumor activity in combination with gemcitabine and cisplatin as compared to mice receiving gemcitabine and cisplatin alone.
Approved indications
- Non-small cell lung cancer
- Squamous non-small cell lung cancer
Boxed warnings
- 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 )
Common side effects
- Rash
- Vomiting
- Diarrhea
- Dermatitis acneiform
- Venous Thromboembolic Events (VTE)
- Hypomagnesemia
- Weight decreased
- Headache
- Pulmonary embolism
- Pruritus
- Dry Skin
- Skin fissures
Key clinical trials
- 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 (PHASE1)
- 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 (PHASE1,PHASE2)
- First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (PHASE3)
- Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD) (PHASE2)
- QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (PHASE1,PHASE2)
- A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer (PHASE1)
- Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer (PHASE1)
- First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Portrazza CI brief — competitive landscape report
- Portrazza updates RSS · CI watch RSS
- Eli Lilly Co portfolio CI