Australia's most trusted source of pharma news
Celgene to bring AML pill to Aust
Posted 7 August 2017
Celgene is preparing to bring its newly FDA-approved acute myeloid leukaemia pill Idhifa (enasidenib) to Australia, seeking both registration and reimbursement.
Idhifa is the first-ever treatment option for patients living with relapsed or refractory AML who also have the isocitrate dehydrogenase-2 (IDH2) mutation, which takes in about 8-19 per cent of the AML patient group.
It is the first new AML treatment approved in several decades and, unlike previous treatments which involved intravenous chemotherapy, Idhifa is an oral medication.
Celgene's Australia and New Zealand Vice President and Managing Director George Varkanis told Pharma in Focus the company was looking to bring the pill to Australia after it won FDA last week.
"Following FDA approval of Idhifa for patients with relapsed/refractory AML with an IDH2 mutation, Celgene plans to seek registration and reimbursement of Idhifa for these patients in Australia," Varkanis said.
Idhifa was developed by Celgene in partnership with US biotech Agios Pharmaceuticals. It was approved in the US just four years after entering clinical trials and approved almost a month ahead of its PDUFA date, along with receiving a Priority Review voucher.
Agios CEO David Schenkein said the FDA approval was "the first of what we expect to be multiple first-in-class precision medicines for patients with cancer and rare genetic diseases".
Idhifa's approval hinged on an open-label, single-arm phase I/II study of relapsed or refractory AML patients with the IDH2 mutation. Study participants demonstrated a complete response or complete response with partial haematologic improvement rate of 23 per cent.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 7 August 2017
Celgene is preparing to bring its newly FDA-approved acute myeloid leukaemia pill Idhifa (enasidenib) to Australia, seeking both registration and reimbursement.
Idhifa is the first-ever treatment option for patients living with relapsed or refractory AML who also have the isocitrate dehydrogenase-2 (IDH2) mutation, which takes in about 8-19 per cent of the AML patient group.
It is the first new AML treatment approved in several decades and, unlike previous treatments which involved intravenous chemotherapy, Idhifa is an oral medication.
Celgene's Australia and New Zealand Vice President and Managing Director George Varkanis told Pharma in Focus the company was looking to bring the pill to Australia after it won FDA last week.
"Following FDA approval of Idhifa for patients with relapsed/refractory AML with an IDH2 mutation, Celgene plans to seek registration and reimbursement of Idhifa for these patients in Australia," Varkanis said.
Idhifa was developed by Celgene in partnership with US biotech Agios Pharmaceuticals. It was approved in the US just four years after entering clinical trials and approved almost a month ahead of its PDUFA date, along with receiving a Priority Review voucher.
Agios CEO David Schenkein said the FDA approval was "the first of what we expect to be multiple first-in-class precision medicines for patients with cancer and rare genetic diseases".
Idhifa's approval hinged on an open-label, single-arm phase I/II study of relapsed or refractory AML patients with the IDH2 mutation. Study participants demonstrated a complete response or complete response with partial haematologic improvement rate of 23 per cent.
Megan Brodie
megan.brodie@lushmedia.com.au
Drought, fire and now virus cut chance of PBS relief.
Don't do it for the accolades; do it for your kids.
New forms of rotavirus vaccine Rotarix.