Tokyo, Japan, and Lugano, Switzerland March 28, 2022 – Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) and Helsinn Group (hereinafter “Helsinn”), announced today that Taiho has been granted approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market the NK1 receptor antagonist antiemetic drug “Arokaris® I.V. Infusion 235mg” (generic name: fosnetupitant chloride hydrochloride) for gastrointestinal symptoms (nausea and vomiting, including delayed phase) associated with cancer chemotherapy (cisplatin, etc.).
Arokaris® is an NK1 receptor antagonist antiemetic drug and is a phosphorylated pro-drug preparation (injection) which is converted to netupitant, the active component. Chemotherapy-induced nausea and vomiting can have deleterious effects on patients’ quality-of-life, and may also interfere with chemotherapy administration, therefore guidelines1-4 recommend adequate prophylaxis.
Taiho, which acquired exclusive development and marketing rights for Arokaris® in Japan under a license agreement with Helsinn in April 2011, has conducted clinical trials in Japan since then, and submitted a new drug application in March 2021.5
This approval is based on the results of a Phase III clinical study (CONSOLE6) comparing the efficacy and safety of Arokaris® versus fosaprepitant in patients receiving highly emetogenic chemotherapy in combination with palonosetron and dexamethasone. The results of this study were published in the Journal of Clinical Oncology.7
Within Taiho’s mainstay field of oncology, the company is also focusing on cancer supportive care. Under a former distribution and license agreement with Helsinn, effective as of January 2004, Taiho has been marketing the 5-HT3 receptor antagonist Aloxi® (generic name: palonosetron hydrochloride) in Japan since April 2010.
Helsinn is pleased to be able to bring this new treatment option for supportive care in cancer to patients in Japan. Taiho will promote the proper use of Arokaris® to ensure that it can make further contributions to patients and healthcare professionals.
Product Information
| Product name | Arokaris® I.V. Infusion 235mg |
| Generic name | Fosnetupitant chloride hydrochloride |
| Indications | Gastrointestinal symptoms (nausea and vomiting, including delayed phase) associated with cancer chemotherapy (cisplatin, etc.) |
| Dosage and administration | For intravenous infusion use, the usual dosage of fosnetupitant is 235mg for adults, once on the first day of cancer chemotherapy, combined with other antiemetic drugs. |
The press release has been prepared in compliance with the Japanese regulations.
References
1 MASCC/ESMO Antiemetic Guideline 2016
2 NCCN clinical practice guidelines in oncology: antiemesis. 2018; Ver.3
3 Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017; 35: 3240-3261
4 Aogi K, Takeuchi H, Saeki T, Aiba K, Tamura K, Iino K, et al. Optimizing antiemetic treatment for chemotherapy-induced nausea and vomiting in Japan: Update summary of the 2015 Japan Society of Clinical Oncology Clinical Practice Guidelines for Antiemesis. Int J Clin Oncol. 2021;26:1-17
5 Taiho Pharmaceutical Submits New Drug Application for NK1 Receptor Antagonist Fosnetupitant for Prevention of Gastrointestinal Symptoms (Nausea and Vomiting) Associated with Cancer Chemotherapy (March 23, 2021, News Release)
https://www.taiho.co.jp/en/release/2021/20210323.html
6 A phase III, randomized, double-blind, multicenter, active control study of Pro-NETU for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving Cisplatin based highly emetogenic chemotherapy (HEC) (JapicCTI-194611)
7 Hata A, Okamoto I, Inui N, Okada M, Morise M, Akiyoshi K, et al. Randomized, Double-Blind, Phase III Study of Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: CONSOLE. J Clin Oncol. 2022;40:180-188