FDA approves drug for peripheral T-cell lymphoma

By Reuters Staff

(Reuters) - Spectrum Pharmaceuticals Inc's drug for the treatment of an aggressive form of blood cancer was granted an accelerated approval by the U.S. Food and Drug Administration on Thursday.

The drug, Beleodaq (belinostat), has been approved for patients with peripheral T-cell lymphoma that has relapsed or has not responded to prior treatment.

The regulator grants an accelerated approval to a drug based on initial trials that show the medicine's benefit for patients with serious conditions with few or no treatment options.

Upon approval, the drug is subject to trials that must confirm its benefit.

Beleodaq works by blocking enzymes that contribute to T-cells becoming cancerous.

The safety and effectiveness of Beleodaq was evaluated in a trial involving 129 patients with relapsed or refractory PTCL. Twenty-six percent had a complete or partial response to treatment.

The most common side effects in Beleodaq-treated patients were nausea, fatigue, fever, anemia, and vomiting.

Beleodaq is the third drug to win approval for the condition since 2009, the other two being Spectrum's injection Folotyn (pralatrexate) and Celgene Corp's drug Istodax (romidepsin).

(c) Copyright Thomson Reuters 2014. Click For Restrictions - http://about.reuters.com/fulllegal.asp