Portrazza (necitumumab)

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Portrazza (necitumumab)

How to buy Portrazza:  You can order Portrazza (necitumumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

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 [1][2].

Recommended dose

Complete information about necitumumab’s dosage and administration can be found here: [1][3].
The standard dosage is:
  • 800 mg as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle [1][3]
  • 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 [3]
  • Administer necitumumab prior to gemcitabine and cisplatin infusion [1].
Consult your treating doctor for personalised dosing.

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 [2].
The active substance in Portrazza, necitumumab, is an epidermal growth factor receptor (EGFR) antagonist [1], 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 [2].

What is necitumumab's approval status?

Necitumumab was approved by:
  • FDA (USA) on November 11, 2015 [4]
  • EMA (EU) on March 4, 2016 [2]
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 10.4, 12.6) versus 9.9 months (95% CI 8.9, 11.1))[3][1]. The 1-year overall survival rate was 47.7 % with necitumumab and 42.8% without [3]. 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 [3][1].
Necitumumab was not found to be an effective treatment in patients with non-squamous NSCLC [2][4].
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 [4].
References
[1] Summary of Product Characteristics [FDA]: Portrazza (necitumumab), Eli Lilly and Co., Nov. 2015.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf
[2] EMA. Human Medicines: Portrazza (necitumumab), 04/03/2016 (last update: 05/12/2016), cited on 15/03/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003886/human_med_001953.jsp&mid=WC0b01ac058001d124
[3] Summary of Product Characteristics [EMA]: Portrazza (necitumumab), Eli Lilly Nederland B.V., Dec. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003886/WC500202694.pdf
[4] FDA News Release: FDA approves Portrazza to treat advanced squamous non-small cell lung cancer, 24/11/2015.
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm474131.htm








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