TGA Approves Mallinckrodt’s Uvadex for Use With Cellex Platform

Australia’s Therapeutic Goods Administration (TGA) has granted Mallinckrodt approval for use of its cancer drug Uvadex (methoxsalen) with the Therakos Cellex photopheresis system for treating adults with chronic graft versus host disease (cGvHD) and skin manifestations of cutaneous T-cell lymphoma (CTCL).

The treatment — in which blood is removed from the patient by machine and white blood cells are isolated and then exposed to medication, followed by irradiation and return to the patient —  is indicated for cGvHD in adults following stem cell transplantation and palliative treatment of skin manifestations of CTCL that doesn’t respond to other treatments.

The Cellex platform combines cell collection, photoactivation and reinfusion technologies in a single closed system and can be operated by a single person.