Portrazza (necitumumab), marketed by Lilly, is a monoclonal antibody used in combination with chemotherapeutic agents to treat metastatic squamous non-small cell lung cancer (NSCLC). It blocks signals that stimulate tumor growth by binding to proteins found on the surface of squamous tumor cells.
How Portrazza works
Most NSCLC tumor cells, and particularly squamous NSCLC tumor cells, express a protein called epidermal growth factor receptor (EFGR) on their surface. Growth factors are naturally produced and stimulate cell growth by binding to EFGRs. When growth factors bind to EFGRs, they send signals to the cell to grow and multiply. By also binding to EGFRs, Portrazza blocks growth factors from binding so they are unable to stimulate cell growth.
Epidermal growth factor receptors are found on healthy cells as well as tumor cells. It can cause side effects because it also binds to EGFR on healthy cells elsewhere in the body.
Portrazza in clinical trials
It was approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic squamous NSCLC on Nov. 24, 2015, based on the results from two international, open-label clinical trials: SQUIRE (NCT00981058) and INSPIRE (NCT00982111).
The SQUIRE study, published in The Lancet in July 2015, compared treatment with Portrazza, added to the dual therapy of gemcitabine and cisplatin, to treatment with gemcitabine and cisplatin alone. Results showed that adding Portrazza improved survival by about seven weeks — patients on the Portrazza combination therapy lived 11. 5 months on average, compared to 9.9 months for patients on dual therapy alone.
The INSPIRE study evaluated the safety and efficacy of Portrazza in nonsquamous NSCLC. Published in The Lancet in March 2015, INSPIRE compared treatment with Portrazza combined with pemetrexed and cisplatin, to treatment with pemetrexed and cisplatin alone. Adding Portrazza did not show benefit in survival compared to dual therapy alone.
Based on these results, the FDA limited the approval of Portrazza to the treatment of squamous NSCLC.
Portrazza, in combination with gemcitabine and cisplatin, is indicated for use in patients with metastatic squamous NSCLC as a first-line therapy, and is intended for patients who have not been treated previously with other chemotherapeutic drugs. It is given as an intravenous infusion over 60 minutes, typically on days one and eight of a three-week cycle.
Two of the most common side effects are low magnesium levels and skin rash, which can be severe. There is a risk of cardiac arrest/sudden death, but most patients who experienced these complications had other health problems, such as cardiovascular or lung disease. It is important to inform health providers about a history of heart disease, low magnesium, chronic obstructive pulmonary disease (COPD), or high blood pressure before beginning Portrazza.
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