Specialised Therapeutics Australia (STA), an Australian biopharmaceutical company and Helsinn, a Swiss group focused on building quality cancer care, announce that the Therapeutic Goods Administration (TGA) has approved Akynzeo for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.
Akynzeo 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.
"Cancer patients are burdened with having to take multiple drugs, often several times per day and certainly multiple times per cycle of chemotherapy, to reduce unwanted side effects. With every increased drug/schedule there is an increased risk of mistakes and/or non-compliance," said Professor Dorothy Keefe, Clinical Ambassador, Transforming Health and Professor of Cancer Medicine, University of Adelaide. "The availability of this combination of drugs, in a single capsule, allows 'once per cycle' dosing (which is even better than once per day dosing) for the benefit of the patient."
The approval of Akynzeo was based on the submission of phase 2 and phase 3 trials with Akynzeo in patients undergoing treatment with moderately and highly emetogenic chemotherapy regimens for a variety of tumour types. The most common adverse reactions reported by = 1% of patients treated with Akynzeo for one or more cycles were headache, constipation and fatigue.
STA chief executive officer Carlo Montagner said Akynzeo was a valuable addition to STA's Oncology Supportive Care portfolio, providing patients with access to an effective and convenient antiemetic therapy. "We look forward to making this drug available to cancer patients around the country, for improved management of some of the most common side effects of chemotherapy, which can severely diminish a patient's quality of life. STA will now seek to have Akynzeo listed on the Pharmaceutical Benefits Scheme for reimbursement."
"This approval paves the way for Australian patients to have access to a new treatment option for CINV," said Riccardo Braglia, Helsinn group chief executive officer. "Helsinn is delighted that the TGA has approved Akynzeo and we look forward to a successful launch in Australia, and to working alongside Specialised Therapeutics Australia, with whom we have a long-standing relationship," said Riccardo Braglia, Helsinn's group chief executive officer. "This approval offers patients access to a new treatment option for CINV prevention that is effective in preventing both nausea and vomiting, particularly in the delayed phase, following emetogenic chemotherapy regimens."
CINV is one of the most common and troublesome side effects of chemotherapy. Its management has been refined over the past several decades, but despite the availability of effective treatments and clear antiemetic guidelines, many patients still suffer from CINV, particularly during the delayed phase after chemotherapy.3 Studies show that patients often receive antiemetic drug regimens that are inconsistent with CINV treatment guidelines, which call for multiple-pathway targeted antiemetic prophylaxis.
Akynzeo provides cancer care teams with two antiemetics in a single oral fixed dose combination capsule. A combination of an NK1 receptor antagonist, a 5-HT3 receptor antagonist and dexamethasone meets guideline recommendations for optimal antiemetic therapy following highly emetogenic chemotherapy.
Akynzeo is an oral, fixed combination of an NK1 receptor antagonist, netupitant, and a 5-HT3 receptor antagonist, palonosetron, in a single capsule, that targets two critical signalling pathways associated with chemotherapy-induced nausea and vomiting (CINV).
Akynzeo was approved on October 10th 2014 by the US Food and Drug Administration (FDA), 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.
On January 22, 2014, the European Medicines Agency (EMA) started to review the submission of Helsinn's Marketing Authorisation Application for netupitant/palonosetron fixed dose combination for the prevention of acute and delayed CINV.
Additional regulatory submissions for netupitant/palonosetron fixed dose combination are underway worldwide.
Specialised Therapeutics Australia Pty Ltd (STA) is a biopharmaceutical company dedicated to working with leading international pharmaceutical and diagnostic companies to provide patient access to innovative healthcare solutions.
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products.