FDA approves Akynzeo to prevent chemotherapy-induced nausea and vomiting
the ONA take:
The U.S. Food and Drug Administration (FDA) has approved Akynzeo, a combination product of netupitant and palonosetron, for the treatment chemotherapy-induced nausea and vomiting (CINV) in patients with cancer.
Akynzeo will be available as a fixed combination capsule made up of the two drugs. Palonosetron, a 5-HT3 antagonist, is available as a single agent both intravenously and orally. The intravenous formulation is effective for both acute and delayed CINV; however, the oral formulation is only approved for the treatment of acute CINV. Netupitant, a novel highly selective neurokinin 1 (NK1) receptor antagonist from the same class of drugs as aprepitant, prevents both acute and delayed phase CINV.
Two clinical trials consisting of 1,720 patients with cancer receiving chemotherapy established the effectiveness of Akynzeo. The first study showed that 98.5% of patients receiving Akynzeo did not experience acute CINV, 90.4% did not experience delayed CINV, and 89.6% did not experience overall CINV after the start of cancer chemotherapy.
Patients taking oral palonosetron only experienced higher incidences of CINV. The second study demonstrated similar results. Adverse effects observed with Akynzeo were headache, asthenia, fatigue, dyspepsia, and constipation.
Akynzeo approved for the treatment chemotherapy-induced nausea and vomiting.
The U.S. Food and Drug Administration has approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy.
Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.
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