FDA approves antiemetic agent for prevention of chemotherapy-induced nausea and vomiting

October 14, 2014

FDA has approved netupitant/palonosetron (Akynzeo, Eisai Inc.) to treat chemotherapy-induced nausea and vomiting (CINV).

FDA has approved netupitant/palonosetron (Akynzeo, Eisai Inc.) to treat chemotherapy-induced nausea and vomiting (CINV).

CINV is one of the most common side effects associated with cancer chemotherapy. Its management has evolved over the years; however, despite the existence of effective treatments and guidelines, many patients still suffer from nausea and vomiting, especially during the delayed phase after chemotherapy.

Akynzeo is a prescription-only, fixed combination capsule containing netupitant and palonosetron which targets two different pathways associated with CINV. Palonosetron is a 5-HT3 antagonist which suppresses nausea and vomiting by inhibiting serotonin binding to the 5-HT3 receptors in the brain. It was approved in 2008 to prevent nausea and vomiting within 24 hours after the start of cancer chemotherapy, also known as the acute phase. Netupitant, an NK1 receptor antagonist, is a newer drug used to prevent nausea and vomiting during the acute phase as well as the delayed phase which lasts 25 to 120 hours after the start of chemotherapy. NK1 receptor antagonists work by blocking substance P from binding receptors in the brain and triggering a vomiting reflex.

Watch a video: Palonosetron's preferred status

The efficacy of Akynzeo was established in two clinical trials that included more than 1,700 participants undergoing treatment with moderately and highly vomit-inducing chemotherapy for a variety of tumor types. The study compared the effectiveness of the combination drug, Akynzeo, to that of oral palonosetron alone.

“The results from the pivotal trials show that Akynzeo provides superior prevention against nausea and vomiting compared with oral palonosetron. As a result, physicians may be able to help patients manage CINV with a treatment that works both at the time of chemotherapy administration, and up to five days following treatment,” said Paul J. Hasketh, MD., Akynzeo pivotal study lead author and chair, Lahey Health Cancer Institute and director of Thoracic Oncology.

Caution should be exercised in patients receiving concomitant medications metabolized by CYP3A4 and use should be avoided in patients with severe hepatic or renal impairment. The most common adverse effects associated w ith the use of Akynzeo in the study trials were headache, weakness, fatigue, indigestion, constipation and erythema. 

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.