On April 29, 2016, EMA adopted an opinion recommending extending the authorized indication of Gazyvaro (obinutuzumab) to treat patients with follicular lymphoma. The medicine is to be used in combination with bendamustine in patients who were previously treated with chemotherapy. Gazyvaro was first authorized in the European Union ("EU") in July 2014 for use in combination with chlorambucil in patients with previously untreated chronic lymphocytic leukemia. The opinion adopted by the Committee for Medicinal Products for Human Use ("CHMP") at its April 2016 meeting is an intermediary step on Gazyvaro's path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on EU-wide marketing authorizations.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
