FDA approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting.
Varubi is approved in adults in combination with other antiemetic agents that prevent nausea and vomiting associated with initial and repeat courses of emetogenic and highly emetogenic cancer chemotherapy.
Varubi is a substance P/neurokinin-1 (NK-1) receptor antagonist. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by certain cancer chemotherapies, particularly in the delayed phase.
Varubi is provided to patients in tablet form.
The safety and efficacy of Varubi were established in three randomized, double-blind, controlled clinical trials where Varubi in combination with granisetron and dexamethasone was compared with a placebo in 2,800 patients receiving a chemotherapy regimen that included highly emetogenic (such as cisplatin and the combination of anthracycline and cyclophosphamide) and moderately emetogenic chemotherapy drugs.
Patients treated with Varubi had a greater reduction in vomiting and use of rescue medication for nausea and vomiting during the delayed phase compared to those receiving the control therapy.
Varubi inhibits the CYP2D6 enzyme, which is responsible for metabolizing certain drugs.
Varubi is contraindicated with the use of thioridazine, a drug metabolized by the CYP2D6 enzyme, because use of the two drugs together may increase the amount of thioridazine in the blood and cause an abnormal heart rhythm that can be serious.
Varubi is marketed by Tesaro Inc. of Waltham, Mass.
Amgen’s supplemental new drug application for Kyprolis (carfilzomib) in relapsed multiple myeloma was granted priority review by FDA.
Amgen said FDA has accepted for priority review the supplemental new drug application (sNDA) of Kyprolis (Carfilzomib) for injection for patients with relapsed multiple myeloma.
The sNDA is designed to expand the current indication to include Kyprolis in combination with dexamethasone for patients who have received at least one prior therapy.
Application based on phase 3 head-to-head trial showing superiority of Kyprolis and dexamethasone over bortezomib plus dexamethasone.
The FDA’s acceptance of the sNDA for Kyprolis follows the recent FDA approval for Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.
The application is based on data from the phase 3 head-to-head ENDEAVOR study, which showed that patients with relapsed multiple myeloma treated with Kyprolis and low-dose dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over bortezomib and low-dose dexamethasone (median progression-free survival [PFS] 18.7 months versus 9.4 months, HR=0.53, 95 percent CI, 0.44 – 0.65; p<0.0001).
Treatment discontinuation due to adverse events and on-study deaths was comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study.
In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the bortezomib arm. There was also an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to bortezomibin ENDEAVOR.
The Prescription Drug User Fee Act target action date is Jan. 22, 2016.
