FDA Approves Netupitant and Palonosetron Combination Capsule for Chemotherapy-Induced Nausea and Vomiting


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The U.S. Food and Drug Administration (FDA) has approved a combination of netupitant and palonosetron (Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy.

The new drug, also known as NEPA, is a fixed-combination capsule comprised of two agents: oral palonosetron, which prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of chemotherapy, and netupitant, which prevents nausea and vomiting during both the acute phase and the delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.

“Supportive care products, such as [NEPA], help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,” said Julie Beitz, MD, Director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Clinical Trial Results

NEPA’s effectiveness was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive NEPA 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%, 90.4%, and 89.6% of NEPA-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%, 80.1%, and 76.5% 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 NEPA in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation. ■

 



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