Switzerland-based pharmaceutical group Helsinn Group has enrolled the first patient in a Phase IIIb study evaluating the safety and tolerability of IV netupitant/palonosetron (NEPA) fixed combination of fosnetupitant/palonosetron compared to oral NEPA for the treatment of CINV in women with breast cancer.
The trial will enrol 400 breast cancer patients receiving multiple cycles of anthracycline-cyclophosphamide (AC) chemotherapy in the US and Europe.
Helsinn Group vice-chairman and CEO Riccardo Braglia said: “The purpose of this study is to add important safety information at the disposal of the physicians to potentially assist them to prescribe antiemetics appropriately in patients receiving AC chemotherapy.”
The IV formulation of NEPA in highly emetogenic chemotherapy in non-AC patients is currently being investigated by the US Food and Drug Administration (FDA) for bioequivalence with oral NEPA. The prescription drug user fee act (PDUFA) of the investigation is expected to be released next month.
The drug development programme comprises a repeated dose safety study to further establish the safety of the intravenous formulation and potentially understand adverse drug reactions that may appear during subsequent clinical practice.
IV NEPA’s safety profile was generally found to be similar to that seen with oral NEPA. No anaphylactic and injection site reactions were reported in the FDA study.
So far, IV NEPA has not been approved for commercial use by any regulatory authority anywhere in the world.
In the US, Akynzeo capsules, an oral fixed combination of palonosetron and netupitant, was approved for use in October 2014. It is used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including highly emetogenic chemotherapy.