The European Medicines Agency, EMEA, concludes its formal validation of the marketing authorization application for Theraloc® (Nimotuzumab) positively
Oncoscience | October 26th, 2007
The application for marketing authorization of Theraloc® (Nimotuzumab) was submitted to EMEA on October 4th, 2007.
After formal validation the application was accepted by the EMEA on October 25th, 2007.
October 25th, 07 has also been set as “day 0” of the application procedure. The list of questions from EMEA is expected in February 2008 (day 120)
The acceptance of the marketing authorization application of Theraloc® -and thus the initiation of the authorization procedure- is the biggest milestone in the six year history of the biotech company Oncoscience AG, in Wedel, Germany.
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