Oncoscience AG reports marketing authorization approval for Theraloc® (Nimotuzumab) in the Ukraine
Oncoscience | October 13th, 2007
On October 12th, 2007 Theraloc® was approved in the Ukraine by the Ministry of Health of Ukraine.
As of now Theraloc® is approved for therapy of cancers of the head and neck, grade III and IV brain tumors of adult patients, as well as for therapy in children with recurrent anaplastic astrocytoma grade III, glioblastoma grade IV, and with diffuse intrinsic pontine glioma.
The marketing authorization approval is an important step for additional marketing authorization approvals in the Europe. The approval also confirms that the direction of the development program is justified and that data are sufficiently qualified.
Theraloc® will be made available to patients in the Ukraine as soon as possible and the approval for the medication in Europe will be actively pursued.
Oncoscience AG, a biotechnology company based in Wedel, Germany is currently conducting three phase III clinical trials with the monoclonal EGFR- antibody, Nimotuzumab.
- Phase III study of 1st line treatment in children with diffuse intrinsic pontine glioma in combination with radiotherapy
- Phase III study in adult patients with grade IV brain tumors after surgery and adjuvant radiotherapy plus chemotherapy
- Phase III study of 1st line therapy in patients with inoperable pancreatic cancer plus chemotherapy