The Food and Drug Administration (FDA) approved a new drug to combat chemotherapy-induced nausea and vomiting (CINV).
Varubi (rolapitant) will be used in combination with other antiemetic drugs to prevent delayed-onset CINV, according to TESARO, the manufacturer of the drug, which is a P/neurokinin1 (NK-1) antagonist.
The drug will be available for commercial use in November 2017.
Varubi was first approved as an oral agent in 2015, and on Monday was granted approval to be administered intravenously for patients being treated with cisplatin, carboplatin or other anthracycline/cyclophosphamide-based chemotherapy agents.
The drug will be packed in ready-to-use dosages, which do not need to be refrigerated or mixed — something that will be beneficial to busy chemotherapy clinics, TESARO mentioned in a release about the approval.
“The approval of Varubi IV represents a significant milestone for TESARO,” Mary Lynne Hedley, Ph.D., President and COO of TESARO, said in a statement.
“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. 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.”
In the phase 3 trial that led to the drug’s approval, patients saw improved complete response (CR) rates in delayed CINV, reported fewer vomiting incidents and had less nausea that interfered with daily living.
Delayed-onset CINV is a common side effect from chemotherapy treatment, and can happen anywhere from 25 to 120 hours after a patient is administered chemo.
For patients who are receiving cisplatin-based highly emetogenic chemotherapy in cycle 1, the most common side effects (5 percent or more of patients) seen were neutropenia (9 percent with Varubi and 8 percent with control group) and hiccups (5 percent versus 4 percent).
In patients receiving moderately emetogenic chemotherapy and combinations of anthracycline and cyclophosphamide in cycle 1, common side effects included decreased appetite (9 percent versus 7 percent), neutropenia (7 percent versus 6 percent) and dizziness (7 percent versus 4 percent.)
“Many health care providers tend to believe that CINV is no longer an unmet need, but the reality is that more than half of patients treated with emetogenic chemotherapy experience delayed CINV, even when prescribed standard preventative therapies, such as a 5-HT3 receptor antagonist and dexamethasone,” said Lee Schwartzberg, M.D., professor of medicine at University of Tennessee Health Science Center. “The FDA approval of Varubi IV gives doctors and nurses a new option to help protect their patients from these often preventable side effects.”