FDA News

FDA approves Varubi IV to prevent chemotherapy-induced nausea and vomiting

The FDA approved IV rolapitant in combination with other antiemetic agents to prevent delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy for adults.

Rolapitant (Varubi, Tesaro), which has a plasma half-life of approximately 7 days, is a highly selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors.

“The approval of Varubi IV represents a significant milestone for Tesaro. The majority of NK-1 receptor antagonist doses are administered intravenously in the U.S., and with the introduction of Varubi IV, we now offer health care providers a unique, easy-to-use option that fits well into standard operating practices of a chemotherapy clinic or hospital,” Mary Lynne Hedley, PhD, president and chief operating officer of Tesaro, said in a company-issued release. “We will continue our efforts to expand awareness of delayed chemotherapy-induced nausea and vomiting, and plan to make this important medicine available next month.”

Two identical phase 3 trials — HEC1 and HEC2, designed to evaluate oral rolapitant following treatment with cisplatin-based highly emetogenic chemotherapy — met their primary endpoints of complete response (HEC1, 72.7% vs. 58.4%; P < .001; HEC2, 70.1% vs. 61.9%; P = .043). Both trials showed significant superiority of 180 mg rolapitant compared with active control in the delayed phase of 25 to 120 hours of chemotherapy-induced nausea and vomiting.

In addition, a phase 3 trial — designed to compare 180 mg oral rolapitant with active control in 1,332 patients receiving moderately emetogenic chemotherapy regimens — met its primary endpoint of complete response (71.3% vs. 61.6%; P < .001) and demonstrated superiority in the delayed phase of chemotherapy-induced nausea and vomiting.

Lastly, the randomized phase 3 bioequivalence study compared IV and oral administration of the agent in healthy volunteers. Researchers randomly assigned volunteers to receive 166.5 mg IV rolapitant or 180 mg oral rolapitant.

The pivotal study demonstrated bioequivalence.

The safety profile appeared consistent with previous clinical trials designed to evaluate oral rolapitant, except for infusion-site reactions observed with the IV formulation.

“Many health care providers tend to believe that chemotherapy-induced nausea and vomiting is no longer an unmet need, but the reality is that more than half of patients treated with emetogenic chemotherapy experience delayed chemotherapy-induced nausea and vomiting, even when prescribed standard preventative therapies, such as a 5-HT3 receptor antagonist and dexamethasone,” Lee Schwartzberg, MD, professor of medicine at University of Tennessee Health Science Center, said in the release. “The FDA approval of Varubi IV gives doctors and nurses a new option to help protect their patients from these often preventable side effects.”

The FDA approved IV rolapitant in combination with other antiemetic agents to prevent delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy for adults.

Rolapitant (Varubi, Tesaro), which has a plasma half-life of approximately 7 days, is a highly selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors.

“The approval of Varubi IV represents a significant milestone for Tesaro. The majority of NK-1 receptor antagonist doses are administered intravenously in the U.S., and with the introduction of Varubi IV, we now offer health care providers a unique, easy-to-use option that fits well into standard operating practices of a chemotherapy clinic or hospital,” Mary Lynne Hedley, PhD, president and chief operating officer of Tesaro, said in a company-issued release. “We will continue our efforts to expand awareness of delayed chemotherapy-induced nausea and vomiting, and plan to make this important medicine available next month.”

Two identical phase 3 trials — HEC1 and HEC2, designed to evaluate oral rolapitant following treatment with cisplatin-based highly emetogenic chemotherapy — met their primary endpoints of complete response (HEC1, 72.7% vs. 58.4%; P < .001; HEC2, 70.1% vs. 61.9%; P = .043). Both trials showed significant superiority of 180 mg rolapitant compared with active control in the delayed phase of 25 to 120 hours of chemotherapy-induced nausea and vomiting.

In addition, a phase 3 trial — designed to compare 180 mg oral rolapitant with active control in 1,332 patients receiving moderately emetogenic chemotherapy regimens — met its primary endpoint of complete response (71.3% vs. 61.6%; P < .001) and demonstrated superiority in the delayed phase of chemotherapy-induced nausea and vomiting.

Lastly, the randomized phase 3 bioequivalence study compared IV and oral administration of the agent in healthy volunteers. Researchers randomly assigned volunteers to receive 166.5 mg IV rolapitant or 180 mg oral rolapitant.

The pivotal study demonstrated bioequivalence.

The safety profile appeared consistent with previous clinical trials designed to evaluate oral rolapitant, except for infusion-site reactions observed with the IV formulation.

“Many health care providers tend to believe that chemotherapy-induced nausea and vomiting is no longer an unmet need, but the reality is that more than half of patients treated with emetogenic chemotherapy experience delayed chemotherapy-induced nausea and vomiting, even when prescribed standard preventative therapies, such as a 5-HT3 receptor antagonist and dexamethasone,” Lee Schwartzberg, MD, professor of medicine at University of Tennessee Health Science Center, said in the release. “The FDA approval of Varubi IV gives doctors and nurses a new option to help protect their patients from these often preventable side effects.”