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FDA Approves Rolapitant for CINV

Richard GrallaThe FDA has approved rolapitant (Varubi) for use in combination with other antiemetic agents to prevent delayed CINV from initial and repeat chemotherapy regimens, including highly emetogenic chemotherapy. 

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

The approval was based on data from several phase III trials of rolapitant in more than 2500 patients receiving various emetogenic chemotherapy agents, including cisplatin, carboplatin, and anthracycline/cyclophosphamide-based regimens. The data showed that adding rolapitant to a 5-HT3 receptor antagonist and dexamethasone was superior to a 5-HT3 receptor antagonist and dexamethasone alone in preventing delayed CINV in patients receiving chemotherapy regimens that were moderately or highly emetogenic.

“Results from the phase III 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,” Lonnie Moulder, CEO of Tesaro, the manufacturer of the drug, said in a statement.

Rolapitant is a potent, selective, NK-1 receptor antagonist, with plasma half-life of approximately 7 days. According to the FDA, activation of NK-1 receptors plays a central role in CINV induced by certain chemotherapies, particularly in the delayed phase, defined as the period from 24 hours to up to 120 hours after the start of chemotherapy.

“While important strides in preventing nausea and vomiting associated with chemotherapy have been made, still up to half of patients receiving emetogenic cancer chemotherapy can experience delayed CINV,”said Richard J. Gralla, MD, professor of Medicine at Albert Einstein College of Medicine. “Because NK-1 receptors are key drivers of CINV, especially in the delayed Phase, NK-1 receptor antagonists such as Varubi, when combined with a 5-HT3 receptor antagonist and a corticosteroid, provide enhanced protection from CINV, and do so in the delayed timeframe where the most help is needed.” 

The most common adverse events associated with rolapitant include neutropenia, hiccups, decreased appetite, and dizziness.

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