Glaxo Gets FDA Approval for Leukemia Drug


October 28, 2009

The Wall Street Journal

The Food and Drug Administration approved Arzerra, a leukemia treatment that will be marketed by GlaxoSmithKline PLC for patients who have failed to respond to other therapies.

Arzerra was developed by U.K.-based Glaxo and Danish company Genmab A/S.

The treatment was approved late Monday under the FDA's accelerated approval mechanism, which allows companies to obtain approval for products based on less clinical data than is typically required and is used for patients considered to have unmet medical needs... Read More