New Oral Antiemetic Agent Gains FDA Approval
Tesaro announced that the Food and Drug Administration (FDA) has approved Varubi (rolapitant) tablets 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 highly emetogenic chemotherapy.
The FDA approval was based on data from three Phase 3 randomized, well-controlled, blinded clinical studies that enrolled over 2,500 patients. Varubi in combination with granisetron and dexamethasone was superior to placebo in combination with granisetron and dexamethasone in the prevention of CINV. The patients' chemotherapy regimen included highly emetogenic (eg, cisplatin, anthracycline plus cyclophosphamide) and moderately emetogenic agents.
Treatment with Varubi led to a significant reduction in vomiting episodes or use of rescue medication during the 25–120 hour period post-administration of highly emetogenic and moderately emetogenic chemotherapy regimens. Patients who took Varubi reported less nausea that interfered with normal daily life and reduced episodes of vomiting or retching over multiple chemotherapy cycles.
Varubi is a selective and competitive antagonist of human substance P/neurokinin 1 (NK1). Varubi is anticipated to launch in the fourth quarter of 2015. The Company announced that an intravenous formulation of rolapitant is also in development.
For more information call (844) 483-7276 or visit TesaroBio.com.