FDA Approves Akynzeo for Chemo-Related Nausea, Vomiting

The FDA has approved combined netupitant and palonosetron (Akynzeo) for the treatment of chemotherapy-related nausea and vomiting in patients with cancer.

Earlier today the US Food and Drug Administration (FDA) approved the combination of netupitant and palonosetron (Akynzeo) for treating cancer patients experiencing chemotherapy-related nausea and vomiting.

The new drug combines two anti-emetics-a new agent, netupitant, and palonosetron, an oral drug first approved in 2008 for preventing chemo-related nausea and vomiting during the acute phase. Netupitant helps prevent nausea and vomiting during the delayed phase, as well as the acute phase.

“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, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, in a press release.

The two randomized trials that led to the approval of the netupitant/palonosetron combination included 1,720 patients who were receiving chemotherapy. Patients were assigned to either single-agent palonosetron or the netupitant/palonosetron combination.

The trials looked at the effectiveness at preventing chemo-related nausea/vomiting during the acute, delayed, and overall phases. The combination drug outperformed palonosetron alone in all three phases.

Data from the first trial showed that during the acute phase 98.5% of patients on the doublet therapy did not experience nausea and vomiting or require rescue medication compared with 89.7% of patients receiving palonosetron alone.

In the delayed phase 90.4% of patients on netupitant/palonosetron did not experience nausea/vomiting vs 80.1% for palonosetron alone.

During the overall phase 89.6% of patients on the doublet therapy did not experience nausea and vomiting vs 76.5% for palonosetron alone. Similar results were seen in the second trial.

Common adverse events experienced by patients who received netupitant/palonosetron were fatigue, constipation, dyspepsia, headaches, and asthenia.