Akynzeo approved for CINV
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The FDA approved Akynzeo for the treatment of nausea and vomiting in patients with cancer who are undergoing chemotherapy.
Akynzeo — a fixed combination capsule composed of palonosetron (Aloxi; Eisai, Helsinn Healthcare) and netupitant (Eisai, Helsinn Healthcare) — is designed to treat nausea and vomiting during the acute and delayed phases after chemotherapy (CINV).
The FDA approved oral palonosetron in 2008 to prevent nausea and vomiting during the acute phase, which occurs during the first 24 hours after a patient undergoes chemotherapy. Netupitant — a novel agent — treats nausea and vomiting during the acute phase, as well as during the delayed phase, or 25 to 120 hours after the start of chemotherapy.
The FDA based its approval of Akynzeo in part on the results of two clinical trials composed of 1,720 patients with cancer who were undergoing chemotherapy. Researchers randomly assigned patients to the combination capsule or oral palonosetron alone.
Results from one of these trials indicated a greater proportion of patients who received the combination capsule did not experience vomiting or require rescue nausea medication during the acute phase (98.5% vs. 89.7%), delayed phase (90.4% vs. 80.1%) or overall phase (89.6% vs. 76.5%).
The second trial demonstrated similar efficacy for the combination of palonosetron and netupitant, according to an FDA press release.
The most common adverse events associated with palonosetron and netupitant were headaches, asthenia, fatigue, dyspepsia and constipation.