European Commission (EC) has approved Varuby (oral rolapitant tablets) for the prevention of chemotherapy-induced nausea and vomiting.-Tesaro

Tesaro announced that the European Commission (EC) has approved Varuby (oral rolapitant tablets) for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults. Chemotherapy-induced nausea and vomiting (CINV) is a frequent and debilitating, yet often preventable, side effect of chemotherapy. Varuby is a selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors that is rapidly absorbed and slowly eliminated, with a plasma half-life of seven days. A single 180 milligram dose (two tablets) of Varuby is to be administered within two hours prior to initiation of each chemotherapy cycle, but at no less than 2?week intervals, as part of combination therapy.

Results from three global Phase III trials of Varuby demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25 to 120 hour period following administration of emetogenic chemotherapy, including cisplatin, carboplatin and anthracycline/cyclophosphamide-based regimens. In addition, patients who received Varuby reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting over multiple cycles of chemotherapy. Results of each of the three Phase III studies were published in The Lancet Oncology in August 2015.