AKYNZEO (palonosetron (chlorhydrate de) / netupitant)

Key points

Unfavourable opinion for reimbursement in adults for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

As a reminder, this medicinal product already benefits from a favourable opinion for reimbursement in adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.

What therapeutic improvement?

Not applicable.

Role in the care pathway?

In adults, to prevent chemotherapy-induced nausea and vomiting, treatment must take into account the time to onset of the nausea and vomiting, as well as the emetogenic potential and administered doses of the chemotherapy.

The guidelines recommend one or more antiemetics, combined with corticosteroids. Several medicinal products can be used: as first-line treatment, serotonin 5-HT3 receptor antagonists (anti-5HT3 or “setrons”), corticosteroids (in particular dexamethasone) and type 1 neurokinin (NK1) receptor antagonists (aprepitant, netupitant).

The addition of aprepitant to [setron + corticosteroid] dual therapy has demonstrated a reduction in the risk of vomiting after highly emetogenic chemotherapy (cisplatin-based for example) compared to the absence of aprepitant.

Role of the medicinal product in the prevention of acute and delayed nausea and vomiting associated with MODERATELY emetogenic cancer chemotherapy

Taking into account both the results and the limitations of the clinical study having evaluated the efficacy of AKYNZEO (netupitant/palonosetron) for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy (MEC), i.e.:

• the absence of demonstration of the non-inferiority of AKYNZEO versus the comparator combining setron + aprepitant (+ dexamethasone) in these patients, despite the study design having scheduled this analysis;
• the heterogeneity of the population included, with patients receiving both moderately and highly emetogenic chemotherapy, which, in particular, makes the choice of comparator questionable;
• the absence of comparison of AKYNZEO with a less aggressive antiemetic treatment recommended in the event of MEC (setron + corticosteroid, in particular).

The Committee deems that, on the basis of currently available data, the role of AKYNZEO (netupitant/palonosetron) cannot be specified for the prevention of acute and delayed nausea and vomiting associated with MODERATELY emetogenic cancer chemotherapy.