The Food and Drug Administration has approved an oral combination of two drugs for the prevention of nausea and vomiting in patients undergoing cancer chemotherapy.
The combination of palonosetron, approved in 2008, and a new drug, netupitant, prevent nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of chemotherapy, according to an FDA press statement. The effectiveness of the combination drug, marketed as Akynzeo by Eisai, was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo or oral palonosetron, the FDA statement said.
In the first trial, 98.5%, 90.4%, and 89.6% of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed, and overall phases, respectively, compared with 89.7%, 80.1%, and 76.5% of participants treated with oral palonosetron.
The second trial showed similar results.Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation, the FDA noted in the statement.