Gastrointestinal Cancer

The FDA has granted fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors have high DKK1 expression.

Although immune checkpoint inhibitors are not yet approved for first-line therapy in these populations, the new research could lead to a new standard of care.

Patients should be selected for therapy based on the FDA approved companion diagnostic for a trastuzumab product.

Trastuzumab-dttb was first approved in January 2019 across all eligible indications, mainly adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer.

Trastuzumab is indicated for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Study finds that glecaprevir/pibrentasvir pan-genotypic efficacy for hepatitis C virus is achieved regardless of whether patients are concurrently receiving gastric acid-reducing drugs.

The FDA approved trifluridine/tipiracil (Lonsurf, Taiho Oncology), also known as TAS-102, as a treatment for certain adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma.

The drug is indicated for those patients who were previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Officials with the FDA approved Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 overexpressing gastric cancer.

The addition of ramucirumab did not improve overall survival in patients with HER2-negative gastric cancer.

The FDA has approved trastuzumab-dkst (Ogivri, Mylan GmbH) as a biosimilar to trastuzumab (Herceptin, Genentech), the first biosimilar for the treatment of certain breast and stomach cancers.