AstraZeneca’s acalabrutinib recommended for EU orphan drug designation

AstraZeneca has announced that its new cancer drug acalabrutinib has been recommended for three orphan drug designations in Europe.

The European Medicines Agency's Committee for Orphan Medicinal Products has adopted positive opinions recommending acalabrutinib for designation as an orphan medicinal product for the treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma, mantle cell lymphoma and lymphoplasmacytic lymphoma.

To be granted orphan status, a medicine must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening, with a prevalence of up to five in 10,000 within the EU.

The drug is being developed alongside Acerta Pharma, a company in which AstraZeneca has a majority equity investment.

Sean Bohen, executive vice-president of global medicines development and chief medical officer at AstraZeneca, said: "The positive opinions underscore the continued need for the development of new therapies in these serious and life-threatening conditions and support our commitment to bring new medicines to patients as quickly as possible."

Acalabrutinib is currently being tested in phase I/II trials as a monotherapy, as well as in combination with immunotherapy or chemotherapies in a range of other blood cancers and solid tumours.