FDA Approves New Oral Combo Drug for CINV

The FDA has approved NEPA (Akynzeo) to treat nausea and vomiting in patients undergoing chemotherapy as part of their cancer treatment.

NEPA is comprised of oral palonosetron and netupitant. Oral palonosetron was approved in 2008 to prevent nausea and vomiting during acute phase (the first 24 hours after the start) of chemotherapy. Netupitant is a new drug that prevents nausea and vomiting during both the acute phase and the delayed phase (from 25 to 120 hours) after the start of chemotherapy.

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

The approval is based on the results of two clinical trials, which enrolled over 1700 patients receiving chemotherapy. Patients on the trials were randomized to receive either 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 chemotherapy.

In the first trial, 1455 chemotherapy-naïve patients were evaluated to find the efficacy and safety of a single oral dose of NEPA versus a single oral dose (0.50 mg) of palonosetron. The study found that the percentage of patients who achieved complete response (CR) during the delayed phase was significantly higher in the NEPA group compared to the palonosetron group (76.9% versus 69.5%; P = .001).

The NEPA group also performed better overall (74.3% versus 66.6%; P = .001) and in the acute phase (88.4% versus 85.0%; P = .047) as well.

Similar results were seen in the second trial, with overall CR rates for NEPA at 81% compared to 76% in the palonosetron group.

The most common side effects of NEPA in the clinical trials were headache, weakness (asthenia), fatigue, indigestion (dyspepsia) and constipation.

Akynzeo is distributed and marketed by Eisai Inc. of Woodcliff Lake, New Jersey, under license from Lugano, Switzerland—based Helsinn Healthcare S.A.