The US Food and Drug Administration (FDA) has approved Akynzeo to treat nausea and vomiting in cancer patients undergoing chemotherapy. Akynzeo is a capsule consisting of two drugs, netupitant and palonosetron.
Palonosetron prevents nausea and vomiting in the acute phase—within the first 24 hours of chemotherapy initiation.
Netupitant prevents nausea and vomiting in the acute phase and the delayed phase—25 to 120 hours after chemotherapy began.
Akynzeo’s effectiveness was established in two clinical trials of 1720 cancer patients receiving chemotherapy. Patients were randomized to receive Akynzeo or oral palonosetron.
The trials were designed to measure whether the drugs prevented any vomiting episodes in the acute, delayed, and overall phases after the start of chemotherapy.
Most Akynzeo-treated patients did not experience any vomiting or require rescue medication for nausea during the acute (98.5%), delayed (90.4%), and overall phases (89.6%).
The same was true for patients who received palonosetron, although percentages were lower—89.7%, 80.1%, and 76.5%, respectively.
The second trial showed similar results.
Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation.
Akynzeo is distributed and marketed by Eisai Inc., under license from Helsinn Healthcare S.A.
