Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has approved LONSURF® as a treatment for 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.
The approval of LONSURF represents a significant milestone for patients living with advanced gastric or GEJ adenocarcinoma who have limited effective treatment options after standard treatment options have failed. We thank all the patients and physicians who helped make this possible through their participation in LONSURF clinical trials,
said Timothy Whitten,
President and Chief Executive Officer,
Taiho Oncology, Inc.
The approval for LONSURF follows an FDA Priority Review designation and is based on data from a global, randomized, Phase III TAGS trial evaluating 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. 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.
Effective treatments for patients with heavily pretreated advanced gastric and GEJ cancer are limited. By improving survival, LONSURF may provide a significant impact on the lives of these patients,
said Martin Birkhofer,
MD, Senior Vice President
and Chief Medical Officer,
Taiho Oncology, Inc.
This approval expands the current indication for LONSURF 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, based on results obtained in the RECOURSE trial.