FDA Approves Akynzeo

The US Food and Drug Administration (FDA) today approved Akynzeo to treat cancer chemotherapy related nausea and sickness.

Akynzeo is a fixed combination capsule comprised of two drugs, (netupitant and palonosetron). First approved in 2008, oral palonosetron, works to prevent nausea and vomiting during the first 24 hours after the initial start of cancer chemotherapy. However, new drug, netupitant, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.

Julie Beitz, MD, director of the FDA Office of Drug Evaluation III, said in a press release, “Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy.”

Within 2 clinical trials of 1,720 participants receiving cancer chemotherapy, participants were randomly selected to receive Akynzeo or oral palonosetron. The trials intended to measure whether the study drugs prevented any vomiting episodes in the acute, delayed, and overall phases after beginning chemotherapy.

Both trial results concluded that 98.5%, 90.4% and 89.6% of participants who received Akynzeo treatment did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. Comparatively, 89.7%, 80.1%, and 76.5% of participants treated with oral palonosetron experienced no vomiting or the necessity for nausea rescue medication during the acute, delayed and overall phases, respectively.

Common side effects of the drug reported in the clinical trials included headache, weakness, indigestion and constipation.

Akynzeo is distributed and marketed by Eisai Inc. in Woodcliff Lake, NJ, under license from Lugano, Switzerland-based Helsinn Healthcare SA.