APL is a subtype of acute myeloid leukaemia (AML) and although it is a rare disease, with an incidence rate of approximately 2-3 patients in every 1,000,000 people this treatment provides a very good result for patients
Phebra’s Chief Executive Officer, Dr Mal Eutick, described the Federal Government’s recent decision to subsidise PHENASEN® as an excellent outcome, saying it will provide newly-diagnosed sufferers with access to this effective treatment for APL.
“Previously we had PBS reimbursement for treatment of relapsed / refractory disease however with the marketing approval in late 2015 for treatment of newly diagnosed patients and now the re-imbursement of this treatment, it’s a successful result for patients, hospitals and clinicians as well as the Company,” Dr Eutick said.
“PHENASEN® is a good example of targeted and effective cancer therapy.”
Dr Eutick said PHENASEN® has been developed by Phebra, in collaboration with leading Australian haematologists, and this injection is being manufactured by Phebra at its new manufacturing facility at Lane Cove West in Sydney.
“This outcome came from an Australian clinical trial run by the Australasian Leukaemia and Lymphoma Group (ALLG) which demonstrated that PHENASEN®, in combination with ATRA and chemotherapy, was a very effective therapy in the treatment of newly diagnosed APL patients. A European clinical trial group also observed similar outcomes,” Dr Eutick said.
“Phebra is the first pharmaceutical company to pursue and achieve registration of arsenic trioxide injection for the treatment of patients with newly diagnosed disease and we are pleased that this was trialled here in Australia and that we have received approval for this use also as an Australian first.”
The PBS listing for PHENASEN® is effective from Friday, April 1, 2016.
The Therapeutic Goods Administration (TGA) granted marketing approval for PHENASEN® in Australia in September, 2015.
Phebra is an Australian based specialty pharmaceutical company which develops, manufactures and markets critical medicines in Australia, New Zealand, Asia, Canada and parts of Europe.
