Acrotech urged to hurry up with confirmatory trial

Indian drugmaker Aurobindo Pharma's (BSE: AUROPHARMA) subsidiary Acrotech Biopharma has been urged to work with the US Food and Drug Administration (FDA) to swiftly advance a confirmatory trial of the cancer drugs Folotyn (pralatrexate) and Beleodaq (belinostat).

Folotyn, an analogue metabolic inhibitor that was approved by the FDA in 2009, and the HDAC inhibitor Beleodaq, which won approval in 2014, are indicated for use as single agents to treat relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare blood cancer.

A condition of the approval was that a further clinical study should be undertaken to approve the efficacy of the drugs, but the data has not yet been produced.