(Reuters) – The European Union medicines regulator on Friday recommended a conditional marketing authorization for U.S. drugmaker Pfizer’s therapy for a type of blood cancer that is difficult to treat.
A committee of the European Medicines Agency (EMA) has recommended use of the therapy, branded as Elrexfio, in adults with multiple myeloma that has returned after at least three prior lines of treatment or whose condition has worsened since the last treatment.
A conditional marketing authorization allows the regulator to recommend medicines with less complete data than normally expected, to facilitate early access to medicines that fulfil an unmet medical need.
Multiple myeloma, a common type of blood cancer, develops in the bone marrow and can spread throughout the body. Several patients see a relapse after stopping treatment, making it an area of unmet need that drugmakers can tap into.
Pfizer’s Elrexfio, or elranatamab, is administered under the skin and belongs to a class of therapies known as bispecific antibodies, which help the body’s immune system kill cancerous cells.
In August, the U.S. Food and Drug Administration granted accelerated approval for the therapy.
(Reporting by Eva Mathews in Bengaluru; Editing by Devika Syamnath)
