Chemotherapy-Related Nausea Treatment Gets FDA Nod

The FDA today granted approval for a treatment that mitigates the sickness cancer patients feel following the start of chemotherapy.

Akynzeo is a fixed combination capsule that combines oral palonosetron, which was approved in 2008 to prevent nausea and vomiting within the first 24 hours after the start chemotherapy, and netupitant, a new drug that halts nausea during both the initial phase and 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,” said Julie Beitz, MD, director of the FDA Office of Drug Evaluation III, in a press release.

In 2 clinical trials that evaluated 1720 participants receiving chemotherapy, patients were randomly assigned to receive either Akynzeo or oral palonosetron in an attempt to measure whether the drugs were able to prevent vomiting episodes during the acute, delayed, and overall phase following the beginning of chemotherapy.

The researchers found that 98.5%, 90.4%, and 89.6% of patients treated with Akynzeo did not experience vomiting or the need for nausea medication during the acute, delayed, and overall phases, respectively. In comparison, 89.7%, 80.1%, and 76.5% of patients who received treatment with oral palonosetron did not experience vomiting or the need for nausea medication during the acute, delayed, and overall phases, respectively.

Common adverse events associated with Akynzeo included headache, weakness, fatigue, indigestion, and constipation.