Officials with the FDA have approved trifluridine/tipiracil (Lonsurf, Taiho Oncology), also known as TAS-102, as a treatment for certain adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, according to the company.

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.

The approval for TAS-102 follows an FDA Priority Review designation and is based on data from a global, randomized, Phase III TAGS trial evaluating Taiho Oncology’s product plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated advanced gastric cancer or GEJ adenocarcinoma following progression or intolerance to previous lines of standard therapy.

TAGS enrolled 507 adult patients with metastatic gastric cancer who had previously received at least 2 prior regimens for advanced disease. The study was conducted in in 17 countries and 110 sites around the world. According to Taiho Oncology, the trial met its primary and secondary endpoints demonstrating prolonged overall survival (OS) with TAS-102 versus placebo, and a safety profile consistent with prior experience with this drug.

“Effective treatments for patients with heavily pretreated advanced gastric and GEJ cancer are limited,” said Martin Birkhofer, MD, Senior Vice President and Chief Medical Officer, Taiho Oncology, in a prepared statement. “By improving survival, Lonsurf may provide a significant impact on the lives of these patients.”

The FDA’s approval expands the current indication for TAS-102 in the United States, where it is currently approved for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with standard chemotherapy. 

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FDA Approves Taiho Oncology’s LONSURF® (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma  [news release]. Princeton, New Jersey; February 25, 2019: Taiho Oncology website. Accessed February 25, 2019.