CHMP positive under exceptional circumstances, for Lumoxiti, for the treatment of relapsed or refractory hairy cell leukaemia.-AstraZeneca

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Lumoxiti, intended for the treatment of relapsed or refractory hairy cell leukaemia. The applicant for this medicinal product is AstraZeneca AB. Lumoxiti will be available as 1-mg powder (with stabiliser solution) for concentrate for solution for infusion. The active substance of Lumoxiti is moxetumomab pasudotox, an antineoplastic agent (ATC code: L01XC34). Moxetumomab pasudotox is a CD22-targeted immunotoxin designed to direct the cytotoxic action of the truncated Pseudomonas exotoxin to cells which express the CD22 receptor. In exceptional circumstances, an authorisation may be granted subject to certain specific obligations, to be reviewed annually. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicinal product, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.