Netupitant Palonosetron Print Email

FDA and EU Commission Approval for Netupitant/Palonosetron (Akynzeo)

In October, 2014, the FDA approved Akynzeo for control of nausea and vomiting in patients undergoing chemotherapy. Akynzeo, developed by Helsinn Healthcare S.A., is a fixed combination capsule that combines the two drugs, netupitant and palonosetron. Oral palonosetron had been previously approved for prevention of these adverse events. Netupitant, a newer drug, is a neurokinin 1 (NK1) receptor antagonist that prevents nausea and vomiting during both the acute  and the delayed phase after chemotherapy. Netupitant is the second substance P/NK1 receptor antagonist to be approved in the US, the first being aprepitant (Emend).

In May, 2015, the EU Commission also approved Akynzeo for the prevention of chemotherapy-induced nausea and vomiting. The decision, based on the opinion issued by the Committee for Medicinal Products for Human Use (CHMP), applies to all 28 European Union member countries, as well as Iceland, Liechtenstein, and Norway.

The effectiveness of Akynzeo was established in three studies headed by Paul Hesketh, Richard Gralla, and Matti Aapro. These included a dose-finding study, and two phase III clinical trials, in which the drug combination was shown to be more effective than oral palonosetron alone. Matti Aapro presented this work at the 2014 MASCC/ISOO Annual Meeting, where he stressed the importance of following antiemetic guidelines with respect to co-administration of medications that target multiple molecular pathways.

Hesketh P, Rossi G, Rizzi G, et al. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study. Ann Oncol. 2014;25:1340–1346. Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4071755/.

Gralla R, Bosnjak S, Honsta A, et al. A phase 3 study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting (CINV) over repeated cycles of chemotherapy. Ann Oncol. 2014;25:1333–1339. Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4071753/. 

Aapro M, Rugo H, Rossi G, et al. A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy. Ann Oncol. 2014;25:1328- 1333. Free full text: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4071754/.