|TESARO Inc (NASDAQ:TSRO) confirms U.S. FDA Approval of VARUBI for Nausea associated with Cancer Chemotherapy|
|By Josh Gee|
|Wednesday, 09 September 2015 22:40|
Oncology-focused biopharmaceutical firm TESARO Inc(NASDAQ:TSRO) has confirmed that U.S. Food and Drug Administration (FDA) has given consent to VARUBI combined with other antiemetic agents in adults for avoiding delayed nausea and vomiting related to repeat courses of emetogenic cancer chemotherapy.
VARUBI is competitive and selective antagonist of human substance P/neurokinin 1 (NK-1) receptors having plasma half-life of about seven days.
The results of Phase 3 trials of VARUBI showed that a huge reduction in episodes of vomiting or even rescue medication in the 25 to 120 hour period after administration of highly emetogenicalong with moderately emetogenic chemotherapy regimens.
Besides this, patients getting VARUBI were found to experience less nausea which interfered with normal daily life as well as some episodes of vomiting over multiple cycles of chemotherapy.
A 180 milligram dose of VARUBI should be given after every one to two hours before the chemotherapy administration along with 5-HT3 receptor antagonist as well as dexamethasone.
Lonnie Moulder, CEO of TESARO, opined that approval of Varubi shows big achievement in the company’s evolution into integrated biopharmaceutical company with strong development as well as commercialization capabilities.
The results demonstrated that patients getting emetogenic chemotherapy agents, including platinum and cyclophosphamide-containing regimens, got the benefit from addition of VARUBI to their antiemetic regimen.
Richard J. Gralla, M.D., Professor of Medicine at Albert Einstein College of Medicine in New York, opined that even though vital progress has been made in ensuring no nausea and vomiting are there in chemotherapy, there are more than half of patients getting emetogenic cancer chemotherapy may experience delayed about Chemotherapy-Induced Nausea and Vomiting (CINV).
.He added that since NK-1 receptors are main drivers of CINV, these along with 5-HT3 receptor antagonist as well as corticosteroid should give more protection from CINV.