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Chemo drug that prevents nausea wins US approval

8 September 2015

Chemo drug that prevents nausea wins US approval

A new drug designed to prevent feelings of nausea and vomiting when undergoing chemotherapy for the treatment of cancer has won approval to bring to market by the US Food and Drug Administration (FDA).

Varubi (rolapitant), marketed by Tesaro, has been approved in combination with other drugs to combat the common side effect of chemotherapy, where the feelings of nausea and vomiting can persist for days after chemotherapy has been administered.

In phase III trials, Varubi demonstrated a significant reduction in episodes of vomiting or use of rescue medication during the 25 to 120 hour period following administration of highly emetogenic and moderately emetogenic chemotherapy regimens. In addition, these patients also reported experiencing less nausea that interfered with normal daily life and fewer episodes of vomiting or retching over multiple cycles of chemotherapy.

Lonnie Moulder, CEO of Tesaro, said: “Results from the Phase 3 trials of Varubi demonstrated that patients receiving emetogenic chemotherapy agents, including platinum and cyclophosphamide-containing regimens, benefitted from the addition of Varubi to their antiemetic regimen.

“Data from multiple well-controlled trials demonstrate that patients who receive only a 5-HT3 receptor antagonist and dexamethasone often continue to suffer from nausea and vomiting for several days following chemotherapy administration.”

Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Centre for Drug Evaluation and Research, said: “Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients' lives and sometimes their therapy. Today’s approval provides cancer patients with another treatment option for the prevention of the delayed phase of nausea and vomiting caused by chemotherapy.”

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