Continue to Site

Drug Discovery and Development

FDA grants orphan drug designation to investigational Novartis drug NIS793

By |

FDA has granted orphan drug designation forNovartis 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.

Filed Under: clinical trials, Drug Discovery, Oncology
Tagged With: , , ,
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Tell Us What You Think!

Related Articles Read More >

Search Drug Discovery & Development