FDA grants orphan drug designation to investigational Novartis drug NIS793

FDA has granted orphan drug designation for Novartis’s (SWX:NOVN) NIS793, an anti-TGF-β IgG2 monoclonal antibody.

Specifically, the designation covers the use of NIS793 in conjunction with standard-of-care chemotherapy to treat pancreatic cancer.

NIS793 has been the subject of eight clinical trials for indications ranging from solid tumors to myelofibrosis.

NIS793 would be a first-in-class antibody specific for transforming growth factor-beta (TGFβ), which is implicated in several tumors. Inhibiting TGFβ can reduce fibrosis associated with pancreatic cancer, according to Novartis.

The prognosis for pancreatic cancer tends to be poor. The five-year survival rate for the cancer ranges from 5% to 10%, according to Johns Hopkins Medicine. Part of the reason for the low survival rate is the generally late diagnosis of the cancer.

Novartis is also testing NIS793 in conjunction with the novel immunotherapy PDR001 in breast and lung cancers trials.

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