VARUBY (rolapitant), NK1 receptor antagonist antiemetic
GASTROENTEROLOGY ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Jan 18 2018
Reason for request
No clinical benefit demonstrated in the prevention of delayed nausea and vomiting after highly and moderately emetogenic chemotherapies
- VARUBY has Marketing Authorisation in prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapies.
- Its benefit compared with placebo has not been demonstrated in prevention of acute nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapies, when acute nausea and vomiting are a predisposing factor to delayed nausea and vomiting.
- In the context of a highly or moderately emetogenic chemotherapy, the available data do not make it possible to assess the benefit of VARUBY in the strategy for prevention of nausea and vomiting which includes: setron + corticosteroid + NK1 receptor antagonist. The impact on morbidity and on quality of life have not been demonstrated to date.
- VARUBY should be reserved for patients who cannot receive triple therapy based on another NK1 receptor antagonist.
Improvement in actual benefit
Évaluation des médicaments