What is Onivyde - Irinotecan and what is it used for?
Onivyde is a cancer medicine used to treat a form of cancer called metastatic adenocarcinoma of the pancreas. "Metastatic" means that the cancer has spread to other parts of the body. Onivyde is used in combination with 5-fluorouracil and leucovorin (two other anticancer medicines) in adult patients with progressive disease despite previous treatment with gemcitabine, an anticancer medicine.
Because the number of pancreatic cancer patients is low, the disease is considered 'rare' and Onivyde was designated an 'orphan medicine' (a medicine used in rare diseases) on 9 December 2011.
How is Onivyde used - Irinotecan?
Onivyde can only be obtained with a prescription and treatment should only be prescribed and administered by a doctor experienced in the use of anticancer medicines.
Onivyde is available as a concentrate for solution for infusion (drip) into a vein. The recommended dose is 80 mg / m2 of body surface area, given every two weeks in combination with 5-fluorouracil and leucovorin. The dose can be changed by the doctor in those patients who develop serious side effects or with particular genetic characteristics that increase the risk of side effects. For more information, see the summary of product characteristics (included with EPAR).
How does Onivyde - Irinotecan work?
The active substance in Onivyde, irinotecan, is an anticancer medicine belonging to the group of "topoisomerase inhibitors". It blocks an enzyme called topoisomerase I, which intervenes in the duplication of cellular DNA, necessary for the formation of new cells. This action prevents the multiplication of cancer cells, which end up dying. In Europe, irinotecan has been authorized for some years for the treatment of colorectal cancer. The irinotecan contained in Onivyde is encapsulated within microscopic fat particles called "liposomes". Liposomes are expected to accumulate inside the tumor and release the medicine slowly, so that irinotecan is eliminated from the body less quickly and can act for a prolonged time.
What benefit has Onivyde - Irinotecan shown during the studies?
Onivyde was analyzed in a main study involving 417 patients with metastatic pancreatic adenocarcinoma with disease progression following gemcitabine treatment. Patients were given Onivyde or 5-fluorouracil plus leucovorin, or three medicines in combination. The main measure of effectiveness was overall survival (how long the patients survived). The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients' lives: patients who had taken the three drugs in combination had survived approximately 6.1 months compared to 4.2 months of patients who had taken 5-fluorouracil plus leucovorin and 4.9 months of patients who were given Onivyde as monotherapy.
What are the risks associated with Onivyde - Irinotecan?
The most common side effects of Onivyde (which may affect more than 1 in 5 people) are diarrhea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), fatigue, weakness, anemia (low red blood cell count), stomatitis (inflammation of the mucous membrane of the mouth) and fever. The most common serious side effects (which may affect more than 1 in 50 people) include diarrhea, nausea and vomiting, neutropenia and fever, blood or lung infections (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low blood platelet levels). For the full list of all side effects reported with Onivyde, see the package leaflet. Onivyde should not be given to patients who have had a severe (allergic) hypersensitivity reaction to irinotecan and breast-feeding women. For the full list of limitations, see the package leaflet.
Why has Onivyde - Irinotecan been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Onivyde's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that the increase in survival observed with the use of Onivyde in combination with 5-fluorouracil and leucovorin was significant in patients with metastatic pancreatic adenocarcinoma previously treated, for which limited treatment options are available; the safety profile of Onivyde is comparable to that of standard irinotecan and its manageable side effects.
What measures are being taken to ensure the safe and effective use of Onivyde - Irinotecan?
Recommendations and precautions to be followed by healthcare professionals and patients for safe and effective use of Onivyde have been included in the summary of product characteristics and the package leaflet.
More information on Onivyde - Irinotecan
For the full EPAR of Onivyde consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Onivyde therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The summary of the opinion of the Committee for Orphan Medicinal Products related to Onivyde is available on the Agency's website: ema.europa.eu/Find medicine / Human medicines / Rare disease designation.
