| Manufacturer || Eli Lilly and Co.
| Disease || Lung Cancer
| Indication || Squamous Non-Small Cell Lung Cancer
| Mode of Action || Epidermal Growth Factor (EGFR) Antagonist (immunotherapy)
| Approval Status || EMA approved (EU); FDA approved (USA)
| CAS Number || 9046114-94-4
| HS Code || 30049000
| Strength || 16 mg/mL
Who is necitumumab for?
Necitumumab is indicated in combination with gemcitabine and cisplatin — two widely approved medicines — for the treatment of patients with metastatic squamous non-small cell lung cancer 
Complete information about necitumumab’s dosage and administration can be found here: 
The standard dosage is:
Consult your treating doctor for personalised dosing.
- 800 mg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle 
- Administered in addition to gemcitabine and cisplatin-based chemotherapy for up to 6 cycles of treatment followed by necitumumab as a single agent in patients whose disease has not progressed, until disease progression or unacceptable toxicity 
- Administer necitumumab prior to gemcitabine and cisplatin infusion .
What is necitumumab and how does it work?
Necitumumab is a monoclonal antibody used to treat adults with metastatic squamous non-small cell lung cancer 
The active substance in Portrazza, necitumumab, is an epidermal growth factor receptor (EGFR) antagonist 
, a type of protein designed to recognise and attach to EGFR on the surface of the cancer cells. EGFR normally controls the growth and division of cells, but in cancer cells EGFR is often overactive, causing the cells to divide uncontrollably. By attaching to and blocking EGFR, necitumumab helps to reduce the growth and spread of the cancer 
What is necitumumab's approval status?
Necitumumab was approved by:
for the treatment of adults with advanced squamous NSCLC.The approvals were based on a study (SQUIRE) involving 1,093 patients with advanced squamous non-small cell lung cancer who received the chemotherapies gemcitabine and cisplatin with or without Portrazza (necitumumab). Patients treated with necitumumab in addition to chemotherapy lived on average 1.6 months longer than those treated with chemotherapy alone (11.5 months (95% CI
- FDA (USA) on November 11, 2015 
- EMA (EU) on March 4, 2016 
10.4, 12.6) versus 9.9 months (95% CI 8.9, 11.1))
. The 1-year overall survival rate was 47.7 % with necitumumab and 42.8% without 
. The median progression free survival (PFS) was 5.7 months (95% CI 5.6, 6.0) when necitumumab was added to the therapy and 5.5 months (95% CI 4.8, 5.6) without necitumumab's addition 
.Necitumumab was not found to be an effective treatment in patients with non-squamous NSCLC .The most common side effects of Portrazza are skin rash and magnesium deficiency (hypomagnesemia), which can cause muscular weakness, seizure, irregular heartbeats and can be fatal. Necitumumab’s serious risks include cardiac arrest and sudden death, as well as hypomagnesemia .