Orphan status for AbbVie’s brain tumour drug

by | 4th Aug 2014 | News

Shares in AbbVie were given a little boost on news that its experimental brain tumour drug has picked up orphan status on both sides of the Altantic.

Shares in AbbVie were given a little boost on news that its experimental brain tumour drug has picked up orphan status on both sides of the Altantic.

The drugmaker said both the US Food and Drug Administration and European Medicines Agency have granted ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, the designation as a treatment for patients with glioblastoma multiforme.

Every year in the US and Europe, two to three out of every 100,000 people are diagnosed with glioblastoma multiforme, the most common and most aggressive type of malignant primary brain tumour, linked with a five-year survival rate of just 4% and for which treatment options are limited.

Early clinical data for ABT-414 look promising. In a Phase I trial, presented at ASCO’s annual meet earlier this year, preliminary responses were noted in three out of nine patients with the condition given the drug, with two partial and one complete response. Phase II studies are currently being planned.

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