FDA approves Spectrum's Beleodaq for PTCL

4 July 2014
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Under its accelerated approval program, the US Food and Drug Administration late yesterday cleared Spectrum Pharmaceuticals’ (Nasdaq: SPPI)Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

Beleodaq works by stopping enzymes that contribute to T-cells, a type of immune cell, becoming cancerous. It is intended for patients whose disease returned after treatment (relapsed) or did not respond to previous treatment (refractory).

$25 million milestone payment for Topotarget

The FDA approval triggers a milestone cash payment of $25 million from Spectrum Pharmaceuticals to Denmark’s Topotarget (Nasdaq OMX: TOPO) under a 2010 licensing deal between the companies. Moreover, Topotarget is eligible to receive double-digit royalties as well as sales milestones of the aggregated net sales. Shares of Spectrum rose 4.6% to $9.12 on the news. Topotarget gained 9.7% to 4.30 Danish kroner in early morning trading.

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