Helsinn Group and Eisai Inc. Announce Inclusion of AKYNZEO® (netupitant/palonosetron) in 2015 NCCN® Antiemesis Guidelines

LUGANO, Switzerland and WOODCLIFF LAKE, New Jersey, April 15, 2015 /PRNewswire/ --

Helsinn Group and Eisai Inc. jointly announced today the decision of the National Comprehensive Cancer Network (NCCN) to include AKYNZEO^® in the 2015 NCCN Antiemesis Guidelines as a recommended option for patients receiving both highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).

AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Approved by the U.S. Food and Drug Administration in October 2014, AKYNZEO is the first approved fixed combination oral agent that targets two distinct signaling pathways associated with chemotherapy-induced nausea and vomiting (CINV) by combining netupitant, an NK₁ receptor antagonist, and palonosetron, a 5-HT₃ receptor antagonist, in a single capsule. Current treatment guidelines for the prevention of CINV call for combinations of medicines - including 5-HT₃ receptor antagonists, NK₁ receptor antagonists, and corticosteroids - based on the emetogenic potential, the likelihood that a drug will cause nausea or vomiting, of the chemotherapy regimen the patient will receive.

"We are pleased that the NCCN has recommended the use of AKYNZEO as an option for patients receiving HEC and MEC," said RuiRong Yuan, MD, Chief Medical Officer, Eisai Global Oncology Business Unit, and Vice President, Medical Affairs, Americas Region, Eisai Inc. "The NCCN Guidelines are an important resource for health care providers and patients. This recommendation provides a guide for decision-making in cancer management, based on the

best available evidence, that may help prevent nausea and vomiting for patients with cancer following chemotherapy."

CINV is one of the most common side effects of chemotherapy. Its management has been refined over the past several decades, but despite the existence of effective treatments and clear antiemetic guidelines, many patients still suffer from CINV, particularly during the delayed phase after chemotherapy.

"Helsinn is delighted with the NCCN recommendation," said Silvia Sebastiani, Head of Medical Education and Post Registration Studies at Helsinn. "This change is in line with our mission of supporting people with cancer, providing them with the tools to help cope with nausea and vomiting caused by anti-cancer treatment."

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) document provides evidence-based, consensus-driven management to help patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care-including physicians, nurses, pharmacists, payers, patients and their families-with the ultimate goal of advancing patient care in the fight against cancer.

About AKYNZEO^® (netupitant/palonosetron)  

AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of a 5-HT₃ receptor antagonist, palonosetron, and an NK₁ receptor antagonist, netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Additional applications for NEPA are planned worldwide. On March 26, 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending that AKYNZEO be granted in the European Union marketing authorization for the prevention of

acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.

AKYNZEO Important Safety Information 

Warnings and Precautions

• Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT₃ receptor antagonists

• Serotonin syndrome has been reported with 5-HT₃ receptor antagonists alone but particularly with concomitant use of serotonergic drugs.  Serotonin syndrome can be life threatening.  Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment.  Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs

Adverse Reactions

• Most common adverse reactions: headache, asthenia, dyspepsia, fatigue, constipation and erythema

Drug Interactions

• Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days