Tesaro Inc. (NASDAQ: TSRO) shares reacted positively in the market Wednesday as positive study results have been released surrounding its lead product. The company announced that the U.S. Food and Drug Administration (FDA) has approved Varubi (rolapitant) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
For some background, chemotherapy-induced nausea and vomiting (CINV) is a debilitating, yet often preventable, side effect of chemotherapy. Up to 50% of patients undergoing highly or moderately emetogenic chemotherapy experience delayed CINV.
This trial met its primary endpoint of complete response (CR) and demonstrated statistical superiority of rolapitant 180 mg compared to active control (5-HT3 receptor antagonist + dexamethasone) in the delayed phase of CINV.
Lonnie Moulder, CEO of TESARO, commented on the release:
The approval of Varubi, our first product, represents a significant milestone in Tesaro’s evolution into an integrated biopharmaceutical company with strong development and commercialization capabilities. 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. Patient surveys and our primary market research also point to the high rate of CINV and its potentially debilitating effects. We look forward to expanding the awareness of CINV and working with healthcare providers to make this important medicine available to patients during the fourth quarter.
Richard J. Gralla, M.D., Professor of Medicine at Albert Einstein College of Medicine in New York, said:
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. 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.
Shares of Tesaro were up 1.6% at $52.49 on Wednesday afternoon. The stock has a consensus analyst price target of $67.83 and a 52-week trading range of $23.00 to $66.95.