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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/243243/2015

EMEA/H/C/003728

EPAR summary for the public

Akynzeo

netupitant / palonosetron hydrochloride

This is a summary of the European public assessment report (EPAR) for Akynzeo. 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 Akynzeo.

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

What is Akynzeo and what is it used for?

Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adult patients with cancer who are receiving chemotherapy (medicines to treat cancer).

Some chemotherapy is known to induce severe nausea and vomiting, and Akynzeo is used in patients receiving either highly emetogenic (vomit-inducing) chemotherapy based on the cancer medicine cisplatin, or other chemotherapies that are moderately emetogenic.

Akynzeo contains the active substances netupitant and palonosetron.

How is Akynzeo used?

Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron. The patient takes one capsule one hour before starting each chemotherapy cycle.

The medicine can only be obtained with a prescription.

How does Akynzeo work?

The two active substances in Akynzeo work by blocking two different mechanisms involved in inducing nausea and vomiting during chemotherapy. Netupitant works by blocking neurokinin-1 (NK1)-

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receptors, which are found in the nervous system and are responsible for the delayed phase of nausea and vomiting (that occurs after the first 24 hours); palonosetron, on the other hand, blocks 5HT₃ receptors in the gut, which are responsible for the immediate phase (that occurs within the first 24 hours).

By having both active substances together, Akynzeo helps provide control for both the immediate and delayed phases of nausea and vomiting than occur following chemotherapy.

One of the active substances, palonosetron, has been authorised on its own in the EU since 2005.

What benefits of Akynzeo have been shown in studies?

In a main study comparing Akynzeo with palonosetron alone, 90% of patients taking Akynzeo (121 out of 135) experienced no vomiting within 5 days of starting highly emetogenic chemotherapy compared with 77% of patients taking palonosetron alone (104 out of 136).

A second main study looked at the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy. Around 88% of patients taking Akynzeo experienced no vomiting on day 1 following the first chemotherapy cycle, compared with 85% of patients taking palonosetron. The figures for day 2 to day 5 were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group. This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment.

What are the risks associated with Akynzeo?

The most common side effects reported with Akynzeo are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%). For the full list of all side effects and restrictions, see the package leaflet.

Why is Akynzeo approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile. The Committee therefore concluded that the medicine's benefits are greater than its risk and recommended that it be approved for use in the EU.

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

A risk management plan has been developed to ensure that Akynzeo 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 Akynzeo, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Akynzeo

The European Commission granted a marketing authorisation valid throughout the European Union for Akynzeo on 27 May 2015

The full EPAR and risk management plan summary for Akynzeo 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 Akynzeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2015.

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Akynzeo

EMA/243243/2015