SP1049C Is Granted Orphan Drug Status for Gastric Cancer

Supratek Pharma recently announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to SP1049C for the treatment of gastric cancer.

Last year, Supratek Pharma obtained FDA clearance for its Investigational New Drug application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract. Recently, Supratek also reached an agreement with the FDA for the design of an SP1049C pivotal phase III study protocol under the Special Protocol Assessment process. A randomized phase III pivotal clinical trial will compare SP1049C plus best supportive care (BSC) vs BSC alone for the treatment of patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach who have failed adjuvant or first- or second-line chemotherapy.