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FDA grants approval for Akynzeo to treat chemotherapy-induced nausea, vomiting

The US Food and Drug Administration has approved Akynzeo, a combination of netupitant and palonosetron, for the treatment of nausea and vomiting in patients undergoing cancer chemotherapy.

The fixed combination capsule Akynzeo is distributed and marketed by Eisai, under license from Switzerland-based Helsinn Healthcare.

Oral palonosetron was approved in 2008 and it prevents nausea and vomiting during the acute phase within the first 24 hours after the start of cancer chemotherapy.

Netupitant is a new drug that prevents nausea and vomiting during both the acute phase and delayed phase from 25 to 120 hours after the commencement of cancer chemotherapy.

The approval is based on data from two clinical trials carried out in 1,720 participants receiving cancer chemotherapy, where they were randomly assigned to receive Akynzeo or oral palonosetron.

The two trials were designed to measure whether the study drugs prevented any vomiting episodes in the acute, delayed and overall phases after the start of cancer chemotherapy.

Common side effects of Akynzeo observed in the clinical trials were headache, weakness, fatigue, indigestion and constipation.