The U.S. Food and Drug Administration has approved the use of Aloxi (palonosetron HCI) injection to prevent acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy to treat children ages one month to 17 years.
This is the first approval of a product for acute chemotherapy-induced nausea and vomiting prevention in patients age one to six months.
The drug, made by Eisai, had previously been approved for use in adults to prevent chemotherapy-induced nausea and vomiting (CINV) in 2003.
The approval is based on a randomized, double-blind, non-inferiority pivotal trial comparing single-dose intravenous Aloxi given 30 minutes prior to chemotherapy with a standard-care IV ondansetron regimen given 30 minutes prior to chemotherapy followed by infusions four and eight hours after the first dose of ondansetron. In the study, within the first 24 hours after chemotherapy, 59.4 percent of patients who received Aloxi had no vomiting or retching, and needed no antiemesis rescue medication, compared with 58.6 percent of the patients who received the ondansetron regimen.
Treatment-emergent adverse events were comparable across both arms of the study, with the most frequently reported events in the Aloxi group being headaches. While the study demonstrated that pediatric patients require a higher Aloxi dose than adults do to prevent CINV, the safety profile is consistent with the established profile in adults, a news release notes.