Conditional European approval for a rare blood cancer drug25 Sep 2015
European health regulators conditionally approved Amgen's Blincyto for acute lymphoblastic leukemia (ALL). The U.S. Food and Drug Administration has approved Blincyto since December 2014, for this rare blood cancer, which has few treatment options once a patient has relapsed.
Blincyto is a so-called bispecific antibody, an emerging class of drugs that could prove more potent than conventional antibodies – the mainstay treatment for many forms of cancers.
The European approval is expected in the coming months
The European Medicines Agency conditionally approves a drug when it is meant for a severely debilitating disease with few or no treatment options, and when the benefits of its immediate availability outweigh the risks.
The conditional approval is granted despite the lack of complete trial data and is renewed annually until the EMA is satisfied with the complete data to fully approve the drug.
Amgen expects final European approval for Blincyto in the coming months.Source: Reuters