First New Fixed Combination Targeting Two Critical Pathways Involved in CINV
Melbourne, Australia, and Lugano, Switzerland, 8 May 2015: Australian biopharmaceutical company Specialised Therapeutics Australia (STA) 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.1
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.1
“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.1
STA Chief Executive Officer Mr 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.2 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.3
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.4
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).1
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.
With the highest professional and ethical standards, we commercialise therapies and technologies that uniquely fulfil the unmet medical needs of our community. The STA therapeutic portfolio and pipeline at present encompass oncology, haematology, urology and ophthalmology.
Additional information can be found at www.specialisedtherapeutics.com.au
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.
Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn’s products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn’s products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.
The efficacy of AKYNZEO® was established in a pivotal, Phase 2, randomised, double-blind, dose ranging study in 694 patients undergoing cisplatin-based chemotherapy for a variety of tumor types. The efficacy of AKYNZEO® was assessed in 135 chemotherapy-naïve patients who received AKYNZEO® (netupitant 300 mg/palonosetron 0.5 mg), and 136 patients who received oral palonosetron 0.5 mg. For the key efficacy endpoints of complete response (CR), defined as no emetic episode and no use of rescue medication, for the delayed phase (25-120 hour interval), the acute phase (0-24 hour interval), and the overall phase (0-120 hours) after the start of chemotherapy administration. AKYNZEO® showed significantly higher CR rates compared with oral palonosetron in the delayed, acute and overall phases (90.4% versus 80.1%; P=0.018; 98.5% versus 89.7%; P=0.007; 89.6% versus 76.5%; P=0.004, respectively).1,5
The clinical efficacy profile was further established in a multinational, randomised, double-blind, parallel-group, Phase 3 study in 1455 chemotherapy-naïve patients receiving anthracycline and cyclophosphamide-based chemotherapy. Patients were randomized to receive a single oral dose of either AKYNZEO® plus dexamethasone or palonosetron plus dexamethasone prior to chemotherapy. The percentage of patients who met the primary endpoint of CR in the delayed phase was significantly higher in the AKYNZEO® group compared to the oral palonosetron group (76.9% versus 69.5%; P = 0.001), which was also seen in the overall (74.3% versus 66.6%; P = 0.001) and acute (88.4% versus 85.0%; P = 0.047) phases post chemotherapy. In this study, AKYNZEO® was generally well tolerated with a safety profile similar to that of palonosetron.6
In a separate study, 309 patients undergoing initial and repeat cycles of chemotherapy (including carboplatin, cisplatin, oxaliplatin, and doxorubicin regimens) received AKYNZEO®; efficacy was maintained throughout all cycles.7
Warning and Precautions1
Use in Specific Populations1
Please review AKYNZEO® Product Information before prescribing at www.specialisedtherapeutics.com.au
AKYNZEO® is under license from Helsinn Group, Switzerland.
For more information about AKYNZEO®, visit www.AKYNZEO.com.