Tag: Glioblastoma
Phase I Trial Results in GBM Lead to Orphan Drug Designation...
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiform.
Phase I Study of ABT-414 Shows Four Objective Responses, Including Complete...
Preliminary results from an ongoing Phase I study with the investigational compound ABT-414 (Abbvie, Inc.,North Chicago, Illinois, U.S.A.), an anti-epidermal growth factor receptor (EGFR) monoclonal antibody drug conjugate or ADC, in combination with temozolomide (Temodar®; Merck & Co., Inc.) which is indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment, showed four objective responses, including one complete response, in patients with recurrent or unresectable glioblastoma multiform. In separate clinical trials ABT-414 is also investigated for the treatment of patients with squamous cell tumors.
