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“Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. Akynzeo’s effectiveness was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo or oral palonosetron. The 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.
Results of the first trial showed that 98.5 percent, 90.4 percent and 89.6 percent of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. In contrast, 89.7 percent, 80.1 percent and 76.5 percent of participants treated with oral palonosetron did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. The second trial showed similar results. Common side effects of Akynzeo in the clinical trials were headache, weakness (asthenia), fatigue, indigestion (dyspepsia) and constipation.