The results demonstrated that complete response (CR) rates for APF530 10 mg dose were non-inferior to palonosetron (Aloxi[R]) during acute CINV (0 to 24 hours) following moderate or highly emetogenic
chemotherapy and also during delayed CINV (24 to 120 hours) following moderately emetogenic
Despite prophylaxis, on the day of chemotherapy, up to 30-45 percent of patients experience nausea or vomiting or require rescue therapy following administration of certain types of emetogenic
CINV remains a clinically significant problem in cancer patients receiving emetogenic
chemotherapy despite the availability of a range of anti-emetic medications.
50 mg dose of palonosetron (PALO) being evaluated for the prevention of CINV following moderately emetogenic
chemotherapy (MEC) showed that NEPA was superior to palonosetron in preventing CINV.
Isolated cases of serious adverse experiences, regardless of causality, of dehydration, enterocolitis, febrile neutropenia, hypertension, hypoesthesia, neutropenic sepsis, pneumonia, and sinus tachycardia were reported in the moderately emetogenic
CINV clinical study.
50 mg (NEPA) for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly and moderately emetogenic
Food & Drug Administration (FDA) on September 12, 2008 for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic
chemotherapy for up to 5 consecutive days.
More than half of patients undergoing emetogenic
chemotherapy may experience delayed CINV, even when prescribed a 5-HT3 receptor antagonist and a corticosteroid
for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic
1] receptor antagonists, and corticosteroids - based on the emetogenic
potential, the likelihood that a drug will cause nausea or vomiting, of the chemotherapy regimen the patient will receive.
Food and Drug Administration (FDA) for AKYNZEO (generic name: netupitant/palonosetron), indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of emetogenic
cancer chemotherapy, including but not limited to highly emetogenic
chemotherapy, in the U.
Despite the widespread use of 5-HT3 receptor antagonist anti-emetics such as Palonosetron (Aloxi; Eisai), chemotherapy induced nausea continues to be reported by 70% of adult patients and 58% of children receiving highly emetogenic