The EMEA said it granted conditional marketing authorization for Arzerra as a treatment for patients with chronic lymphocytic leukemia who don't respond to fludarabine or Campath, a drug sold by Genzyme Corp. (GENZ).
However, the agency added it wants to see further clinical data about long-term use of Arzerra and data on a specific group of patients who don't respond to fludarabine but can't be given Campath.
An agency spokeswoman said conditional marketing authorization is granted when there's a real need for medicines in serious illnesses.
"We need additional data but nevertheless the benefit is considered quite high," said the spokeswoman.
Also Friday, the EMEA said it approved Arepanrix, a second swine flu vaccine from GlaxoSmithKline.
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