Pixuvri - Pixantrone

What is Pixuvri - Pixantrone?

Pixuvri is a medicine that contains the active substance pixantrone. It is available as a powder for the preparation of a solution for infusion (drip into a vein).

What is Pixuvri - Pixantrone used for?

Pixuvri is indicated in the treatment of adult patients with non-Hodgkin B-cell lymphoma, a cancer of the lymph tissue (a part of the immune system) that affects a type of white blood cell called "B lymphocyte" or "B cell". Pixuvri is used when the lymphoma is aggressive and has returned or has not responded to chemotherapy treatments (medicines used in the treatment of tumors).

The medicine can only be obtained with a prescription.

How is Pixuvri used - Pixantrone?

Pixuvri should be administered by a doctor experienced in the use of anticancer medicines and who has the necessary equipment and facilities for patient monitoring.

The dose of Pixuvri is calculated based on the patient's body surface area (calculated using the patient's weight and height). The recommended dose is 50 mg / m2 to be administered by intravenous infusion over at least 60 minutes on days 1, 8 and 15 of a 28-day treatment cycle. Pixuvri can be given up to a maximum of six cycles. In patients who experience side effects or who have very low blood levels of neutrophils (a type of white blood cell that fights infection) and platelets (components that promote blood clotting), it may be necessary to reduce the dose or delay the treatment.

How does Pixuvri - Pixantrone work?

The active substance in Pixuvri, pixantrone, is a cytotoxic medicine (a medicine that can kill cells that divide, such as cancer cells) belonging to the "anthracycline" group. It works by interfering with the DNA present in the cells, preventing them from producing more copies of DNA and making proteins. This means that cancer cells in non-Hodgkin's B-cell lymphoma, unable to divide, end up dying.

What studies have been carried out on Pixuvri?

The effects of Pixuvri were first tested in experimental models before being studied in humans.

Pixuvri has been compared to other chemotherapeutic treatments in a main study involving 140 adults with aggressive non-Hodgkin B-cell lymphoma who had previously undergone at least two other treatments and where the tumor had recurred or he had not responded to treatment. Patients were given six cycles of Pixuvri or another approved anticancer medicine chosen by their doctor.

The main measure of effectiveness was the number of patients who had fully responded to treatment.

What benefit has Pixuvri shown during the studies?

Pixuvri has been shown to offer benefits to patients with an aggressive form of non-Hodgkin B-cell lymphoma: 20% of patients fully responded to Pixuvri (14 of 70 patients) compared to 5.7% of patients treated with other medicines ( 4 patients out of 70).

What is the risk associated with Pixuvri Zentiva?

The most common side effects with Pixuvri (seen in more than 1 patient in 10) are neutropenia, leukopenia and lymphopenia (low concentrations of different types of white blood cells), thrombocytopenia (low concentrations of blood platelets), anemia (low concentrations of red blood cells in the blood), nausea, vomiting, skin dyschromia (changes in skin color), hair loss, chromaturia (abnormal urine staining) and asthenia (weakness). For the full list of all side effects reported with Pixuvri, see the package leaflet.

Pixuvri should not be used in patients who are hypersensitive (allergic) to pixantrone or any of the other ingredients. It must not be used in patients with severe liver problems and in patients in whom the bone marrow produces exceptionally low levels of blood cells. Patients treated with Pixuvri should not be vaccinated with vaccines containing attenuated viruses (weakened living).

Why has Pixuvri - Pixantrone been approved?

The CHMP concluded that patients with aggressive non-Hodgkin's B-cell lymphoma responded better to treatment with Pixuvri than other cancer therapies. Furthermore, subjects treated with Pixuvri survived longer without their disease getting worse. The CHMP also considered the severity of the disease and the lack of adequate alternative treatments for patients in whom non-Hodgkin B-cell lymphoma reappeared or did not respond to other chemotherapy treatments. The side effects of the medicine are short term and appear manageable.

However, the committee noted that more data are needed on the benefits of Pixuvri in patients who have been treated with rituximab (another frequently used medicine to treat lymphoma) in the past. The CHMP concluded that Pixuvri's benefits are greater than its risks and recommended that it be given marketing authorization.

Pixuvri has obtained a "conditional approval". This means that further information on the medicine is expected, in particular on the benefits to patients who have previously been treated with rituximab. Every year the European Medicines Agency will review any new information that may be available and, if necessary, this summary will be updated.

What information is still awaited for Pixuvri?

The company that produces Pixuvri will conduct a study to further analyze the effects of using Pixuvri in patients who have previously been treated with rituximab.