AbbVie's glioblastoma drug granted orphan status in US, EU
- ABT-414 is an anti-epidermal growth factor (EGFR) receptor antibody drug conjugate for the treatment of glioblastoma multiforme.
- The FDA and the EMA have approved use of ABT-414 as an orphan drug based on the unmet medical need associated with this deadly cancer, and because of the small population of affected individuals -- 2 to 3 of every 100,000 people have glioblastoma multiforme .
- Glioblastoma multiforme is the most aggressive type of primary malignant brain tumor.
Because EGFR is highly expressed in many types of cancerous tumors, AbbVie's goal is to deploy this antibody-based therapy in some of the hardest-to-treat cases. And with a five-year survival rate of just 4%, glioblastoma multiforme certainly qualifies as hard-to-treat.
Phase I data evaluated ABT-414 in nine patients. Three of the nine had preliminary responses. Two of the nine had partial responses, and one patient had a complete response. Planning for phase II trials is underway, and AbbVie saw its stock rise slightly on news of the orphan drug designation.
- Pharma Times Orphan status for AbbVie's brain tumour drug