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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/515476/2016

EMEA/H/C/004125

EPAR summary for the public

Onivyde

irinotecan

This is a summary of the European public assessment report (EPAR) for Onivyde. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Onivyde.

For practical information about using Onivyde, patients should read the package leaflet or contact their doctor or pharmacist.

What is Onivyde and what is it used for?

Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas. Metastatic means that the cancer has spread to other parts of the body. Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.

Because the number of patients with pancreatic cancer 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?

Onivyde can only be obtained with a prescription and treatment should only be prescribed and given by a doctor who has experience in the use of cancer medicines.

Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein. The recommended dose is 80 mg per square metre of body surface given every 2 weeks together with 5-fluorouracil and leucovorin. The dose may be adjusted by the doctor in patients who develop severe side effects and those with particular genetic characteristics that increase the risk of side effects. For further details see the summary of product characteristics (also part of the EPAR).

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How does Onivyde work?

The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group 'topoisomerase inhibitors'. It blocks an enzyme called topoisomerase I, which is involved in copying cell DNA, which is needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die. In Europe, irinotecan has been authorised for a number of years for the treatment of colorectal cancer. In Onivyde, irinotecan is contained within tiny fat particles called 'liposomes'. The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby decreasing the rate at which irinotecan is removed from the body and allowing it to act for longer.

What benefits of Onivyde have been shown in studies?

Onivyde was investigated in one main study involving 417 patients with metastatic adenocarcinoma of the pancreas whose cancer got worse despite cancer treatment that contained gemcitabine. Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination. The main measure of effectiveness was overall survival (how long the patients lived). The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients' lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone.

What are the risks associated with Onivyde?

The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts) stomatitis (inflammation of the lining of the mouth) and fever. The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets). For the full list of all side effects reported with Onivyde, see the package leaflet.

Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women. For the full list of restrictions, see the package leaflet.

Why is Onivyde 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 seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.

What measures are being taken to ensure the safe and effective use of Onivyde?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onivyde have been included in the summary of product characteristics and the package leaflet.

Other information about Onivyde

The European Commission granted a marketing authorisation valid throughout the European Union for Onivyde on 14 October 2016 of issue of the Marketing Authorisation.

The full EPAR for Onivyde can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Onivyde, 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 for Onivyde can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.

This summary was last updated in 10-2016.

Onivyde

EMA/515476/2016

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