European regulators have assigned Eisai’s amatuximab with an orphan drug designation (ODD) for the treatment of malignant mesothelioma.
Malignant mesothelioma is a rare and aggressive form of lung cancer caused by exposure to asbestos, affecting around 1 in 50,000 people per year in Europe.
Although there has been a dramatic decline in the use of asbestos since the mid 1970s, incidence of the difficult-to-treat condition is expected to rise.
This, coupled with the particularly poor prognosis linked with the disease – patients can expect median survival from the time of diagnosis of nine-12 months – underscores the urgent need for new treatment approaches.
Eisai’s investigational monoclonal antibody is said to have a high affinity for the protein mesothelin, which is over-expressed in patients with the condition, and is therefore a key target in the search for novel therapies.
A Phase II Study is currently being conducted to assess the effect of the drug, which was developed by Eisai subsidiary Morphotek, when given alongside pemetrexed and cisplatin to patients with mesothelioma in the US and EU.
According to Gary Hendler, president and chief executive of Eisai EMEA & Russia, the ODD for amatuximab “highlights the need for new effective treatments for people with malignant mesothelioma and the potential for this investigational drug”.
