Taiho Oncology Inc, an R&D-driven specialty pharma focused on oncology, allergy and immunology and urology, revealed on Monday the receipt of approval from the US Food and Drug Administration (FDA) for LONSURF for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma based on data from a global, randomised, Phase III TAGS trial.
Gastric cancer is the 15th most commonly diagnosed cancer in the US. Metastatic gastric cancer (mGC) is associated with a five-year survival rate of about 5%.
The company said the US Food and Drug Administration (FDA) has approved LONSURF for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
According to the company, LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.
Under the global, randomised, Phase III TAGS trial, the company evaluated LONSURF 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. The trial met its primary and secondary endpoints demonstrating prolonged overall survival (OS) with LONSURF versus placebo, and a safety profile consistent with prior experience with this drug.
Additionally, the full results from the TAGS trial were presented at the European Society of Medical Oncology (ESMO) 2018 Congress with a simultaneous publication in The Lancet Oncology, concluded the company.
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