Orphan drug status for targeted CLL treatment

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Emergent BioSolutions announced this week that the US Food & Drug Association has granted the company orphan drug status to its sole oncology drug product TRU-016 for the treatment of chronic lymphocytic leukemia (CLL).

TRU-016 is a novel CD37-targeted therapy.

Emergent BioSolutions is currently running a handful of Phase I clinical trials testing the safety of TRU-016 in humans with CLL and similar B-cell malignancies such as non-Hodgkin's lymphomas.

Source: Emergent BioSolutions

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