UPDATE ON THE CURRENT SHORTAGE ON THE ANTI-BODY DINUTUXIMAB (CH14.18/CH0) – PART OF IMMUNOTHERAPY TREATMENT

ANZCHOG STATEMENT:
“Due to manufacturing limitations United Therapeutics has made a decision to discontinue supply of Dinutuximab to Australia. An alternative product, Dinutuximab Beta, marketed by EUSA Pharmaceuticals, is currently available in Australia through a Managed Access Program but is very expensive. Applications to fund the supply of Dinutuximab beta can be made by individual oncologists with the support of their Hospital executive. Applications need to be made on an individual basis. ANZCHOG is committed to working with the two Pharmaceutical companies and clinical trials groups to try to ensure ongoing access to Dinutuximab for children with neuroblastoma.”

EUSA Pharma make Dinutuximab Beta and have confirmed currently they can supply the product into Australia and New Zealand under their Managed Access Program at a cost. The cost of this drug is high and ultimately the decision to fund will lie with each individual State’s Health Department. Currently, we are not aware of any decision being made by any State concerning funding for this drug.

United Therapeutics explained the situation as to why they have had to stop supply to Australia and New Zealand as follows :

United Therapeutics Corporation (UTC) recognizes that dinutuximab is an important treatment
option for pediatric patients with high-risk neuroblastoma in Australia and New Zealand. As we
do not have regulatory approval in these countries, UTC has provided dinutuximab free-of charge
to children as part of an expanded access program. Unfortunately, commercial and
investigational demands for dinutuximab have significantly exceeded our expectations and have
surpassed our current manufacturing capabilities. Our manufacturing restraints have compelled
us to make several tough decisions. In order to continue to meet the needs of patients in National
Cancer Institute (NCI) sponsored studies, UTC-sponsored studies, and commercial markets, both
non-UTC sponsored development activities and expanded access programs have had to be
limited.
For the foreseeable future, we will not be able to fulfil requests for patients to enter into the
dinutuximab expanded access program in Australia and New Zealand. We certainly understand
and appreciate the concern this creates with parents and caregivers.
At this juncture, we cannot provide a reliable estimate for when additional dinutuximab can be
made available for the dinutuximab expanded access program in Australia and New Zealand.
Please allow me to assure you that UTC is focused on bringing patients with chronic and lifethreatening
conditions innovative products that address unmet medical needs. We are in the
process of expanding our manufacturing capabilities to accommodate existing and future requirements for
dinutuximab. Development of a new 20,000-square-foot production facility with the capability of more than quadrupling available quantity of dinutuximab has begun.

United Therapeutics Corporation remains committed to patients with cancer and the oncology community. We believe that the significant additional investment in dinutuximab’s manufacturing is the best path to ensure current and future supplies.

RESEARCH NEWS: Burtomab has just been designated by the US Food and Drug Administration as a breakthrough drug for children with relapsed or refractory neuroblastoma with central nervous system or leptomeningeal metastasis. This will speed up the time it takes to make this therapy available to the children. Currently there are no drugs available to treat this type of advance neuroblastoma. For more details see: tinyurl.com/y8x37yue ...

Neuroblastoma Australia
Ste 3, 165 Sailors Bay Rd
Northbridge NSW 2063
0406 991 606
info@nb.org.au
Neuroblastoma Australia Incorporated is a registered charity with GDR Status . ABN 74 173 375 414.