December 13, 2016 / 6:07 AM / 8 months ago

BRIEF-EU grants Genmab marketing approval for Arzerra combination

Dec 13 (Reuters) - Danish pharmaceutical company Genmab :

* European Commission grants marketing authorisation for Arzerra (Ofatumumab) in combination with Fludarabine and Cyclophosphamide for treatment of adult patients with relapsed chronic lymphocytic leukemia (CLL)

* Approval follows Nov. 10 recommendation, where the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending that Arzerra be approved in this indication

* Approval based on data from Phase III COMPLEMENT 2 study Source text for Eikon: Further company coverage: (Reporting by Annabella Pultz Nielsen)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below