Accelerated FDA Approval for GSK and Genmab's Arzerra

Arzerra, a leukemia treatment for patients who have either stopped responding or have altogether failed to respond to other treatments and therapies, has received accelerated approval by the Food and Drug Administration as of Monday. The treatment will be marketed by GlaxoSmithKline PLC.

Developed by Denmark's Glaxo and Genmab, Arzerra was awarded approval under the Administration's accelerated approval scheme, under which companies can obtain approval for their products based on presentation of less clinical data than is otherwise required for a traditional approval. This type of approval has been designed to meet the needs of patients who currently have unmet medical requirements.

Aimed at treating patients with Chronic Lymphocytic Leukemia (CLL), who have stopped responding to current treatments and their disease is progressing, Arzerra's effectiveness was tested on 181 patients, 59 of who responded positively to the drug.

Arzerra, while being touted as one of the best medicines of current times, has its limitations. The FDA has warned that patients who are at a high Hepatitis B risk must be screened before the drug administered to them.