On November 28, 2017 Purdue Pharma (Canada) reported that AKYNZEO (netupitant/palonosetron hydrochloride) capsules are now available to Canadian cancer patients for the prevention of chemotherapy-induced nausea and vomiting (CINV) (Press release, Purdue Pharma, NOV 28, 2017, View Source [SID1234522278]).
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AKYNZEO (netupitant/palonosetron hydrochloride) capsules received Notice of Compliance (NOC) from Health Canada on September 28, 2017 and is the first approved fixed dose combination oral agent that targets two critical signalling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV[i].
The effects of chemotherapy can vary from patient to patient and CINV is often a common side effect that can occur during a patient’s chemotherapy treatment. If left uncontrolled, CINV may lead to dehydration, electrolyte imbalances, loss of appetite, fatigue and a reduced quality of life[ii].
David Pidduck, President and CEO, Purdue Pharma (Canada), commented: "Cancer, an upsetting and often overwhelming diagnosis for patients and their families, requires safe and effective therapies that not only attempt to save patient lives, but also increase their quality of life. We are proud to bring AKYNZEO to market in Canada. We believe it is an important and novel treatment in cancer supportive care that will offer physicians and their patients a new option to help mitigate the distressing effects of chemotherapy-induced nausea and vomiting."
Purdue Pharma (Canada) has been granted from Helsinn Healthcare S.A. (hereafter "Helsinn"), a Swiss Group focused on building quality cancer care, the exclusive right to register, market, promote, distribute and sell AKYNZEO in Canada. Helsinn will retain clinical development activities, as well as the manufacture and supply of AKYNZEO to Purdue Pharma (Canada).
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About AKYNZEO
AKYNZEO (netupitant/palonosetron hydrochloride), in combination with dexamethasone, is indicated for once per-cycle treatment in adult patients for the prevention of acute delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy as well as for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone. It is the first approved fixed dose oral combination agent that targets two critical signaling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV. The most common adverse events reported with AKYNZEO in clinical trials were headache (3.6%), constipation (3.0%) and fatigue (1.2%)i.
AKYNZEO has been recommended under the antiemetic guidelines of the National Comprehensive Cancer Network (NCCN), an alliance of the world’s leading cancer centers, both in Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC). It is also recommended in the Clinical Practice Guidelines from the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) as one of the therapeutic options to facilitate the application of antiemetic standard of care for patients receiving HEC regimens by preventing nausea and vomiting in both the acute and delayed phases following chemotherapy treatment.
Purdue Pharma (Canada) will be the sole distributor for AKYNZEO in Canada under terms of the current commercialization contract with Helsinn Group. AKYNZEO is already approved in 47 countries including the US, EU, Switzerland and Australia.
Please consult the Product Monograph posted at www.purdue.ca for complete administration and safety information.