Portrazza - Necitumumab

What is and what is Portrazza - Necitumumab used for?

Portrazza is a medicine for the treatment of advanced stages of a type of lung cancer, called non-small cell lung cancer with scaly histology.

Portrazza is administered only in adults, whose tumor cells present a specific protein (EGFR) on the surface and is given in combination with gemcitabine and cisplatin.

It contains the active substance necitumumab.

How is Portrazza used - Necitumumab?

Portrazza is administered by an intravenous infusion (drip) lasting an hour. The recommended dose is 800 mg on day 1 and day 8 of each 3-week cycle. For the first 6 cycles, Portrazza is administered in combination with gemcitabine and cisplatin; subsequently, it is administered alone until the disease remains stable and the patient can tolerate the drug.

During the infusions, it is necessary to have appropriate resources available to manage the onset of any reactions. In case of infusion reactions or severe skin reactions, it may be necessary to stop the treatment permanently. The risk of reactions can be reduced by changing the dose or rate of infusion, or by using preventive medicines. For more information, see the summary of product characteristics (included with EPAR).

Portrazza is available as a concentrate to prepare a solution and can only be obtained with a prescription.

How does Portrazza - Necitumumab work?

The active substance in Portrazza, necitumumab, is a monoclonal antibody (a type of protein) designed to recognize the EGFR protein and bind to it on the surface of cancer cells. Under normal conditions, the EGFR protein controls the growth and division of cells, but in cancer cells this protein is often overactive and causes uncontrolled division. Necitumumab binds to EGFR and blocks it, thus helping reduce the growth and spread of the tumor.

What benefits of Portrazza - Necitumumab have been shown in studies?

A main study of 1, 093 patients with non-small cell lung cancer with advanced-stage squamous cell histology has shown that adding Portrazza to gemcitabine and cisplatin-based chemotherapy can lead to a modest improvement in survival . In this study, patients treated with Portrazza in addition to chemotherapy lived on average 1.6 months more than those treated with chemotherapy alone (11.5 months compared to 9.9 months).

Most patients (95%) had cancer cells with EGFR. Survival did not improve in patients with tumor cells without EGFR.

What are the risks associated with Portrazza - Necitumumab?

The most common side effects of Portrazza (which may affect more than 1 in 10 people) are: skin reactions, vomiting, stomatitis (inflammation of the lining of the oral cavity), fever, weight loss and low levels of different minerals (magnesium, calcium, phosphorus and potassium) in the blood. The most common serious side effects are severe skin reactions (6% of patients) and blood clots (4% of patients). For the full list of all side effects reported with Portrazza, see the package leaflet.

Portrazza should not be used in patients who have had a serious or life-threatening reaction to any of the ingredients of the medicine.

Why has Portrazza - Necitumumab been approved?

In the main study, the addition of Portrazza to gemcitabine and cisplatin-based chemotherapy produced a modest improvement in survival of a month and a half, without causing a significant worsening of patients' overall health. As a result, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Portrazza's benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Portrazza - Necitumumab?

A risk management plan has been developed to ensure that Portrazza is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Portrazza, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that markets the medicine will provide doctors with educational material containing information on the risk of developing blood clots and the small number of cardiac arrest cases observed in the studies.

Further information is available in the summary of the risk management plan.