FarmaMondo has been nominated by EUSA Pharma to exclusively manage access to its innovative drug Dinutuximab beta EUSA in all the CIS countries and in Georgia, to fulfill unmet medical needs of patients with high-risk neuroblastoma.
This Managed Access Program (MAP) also known as named patient program – provides a mechanism that enables physicians to legally and ethically prescribe Dinutuximab beta EUSA to patients who meet specified medical criteria and where funding can be secured.
Dinutuximab beta is an anti-GD2 monoclonal antibody that has shown to significantly improve event-free and overall survival in children with high-risk neuroblastoma, with an acceptable safety profile. Dinutuximab beta EUSA has been approved in May 2017 by the EU medicines agency (EMA) for the treatment of patients with high-risk neuroblastoma.
All requests must be submitted by the treating physician on behalf of the patient. Healthcare providers can obtain details about the Dinutuximab beta EUSA MAP by contacting FarmaMondo’s Program Manager at +41 91 697 6390, or emailing cis.neuroblastoma@farmamondo.com .
About Neuroblastoma and Dinutuximab beta.
Neuroblastoma is an orphan oncology condition with significant unmet medical need. It accounts for up to 10% of childhood tumors. Dinutuximab beta was used extensively across Europe under a managed access scheme before the EMA marketing authorisation and is included in a number of treatment protocols for high-risk neuroblastoma.
Dinutuximab beta, an anti-GD2 monoclonal antibody, is indicated for children aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease. In patients with previous relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Dinutuximab beta should be combined with interleukin-2 (IL-2). Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilized by other suitable measures.
About FarmaMondo
FarmaMondo, established in 1915, is a Swiss-based pharmaceutical service provider focusing on facilitating patients’ access to their unmet medical needs via regulated access mechanisms known as Early Access, Named Patient and Compassionate Use.
FarmaMondo collaborates with innovators who seek to establish pre-commercial availability of their novel therapies to highly targeted groups of patients in territories where medical needs are unmet, in an ethical and compliant manner.
FarmaMondo is the Unlicensed Medicine access partner for thousands of Healthcare Professionals and Institutions globally who seek an ethical and compliant service provider to address their needs for therapies which are commercially unavailable in their home country.
FarmaMondo presence in Russia & CIS has recently been upgraded by establishing a local representative office in Moscow. For more information about FarmaMondo please visit www.farmamondo.com.
About EUSA Pharma
EUSA Pharma is a specialty pharmaceutical company with commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world.
EUSA Pharma has a focus on oncology and oncology supportive care, having currently a broad portfolio of approved and named-patient specialty hospital products, which the company has ambitious plans to expand through acquisition and in-licensing.
For more information about EUSA Pharma please visit www.eusapharma.com.
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Contact Details
FarmaMondo HQ, Switzerland
Tel: +41 91 697 6390
Email: cis.neuroblastoma@farmamondo.com
FarmaMondo Representative Office Russia & CIS
Dinutuximab beta EUSA MAP – CIS Regional Manager – Dr. Georgy Paroshin
Tel: +7 916 020 7310
Email: russia@farmamondo.com
