FDA has approved Truseltiq (infigratinib) from Brisbane, Calif.-based QED Therapeutics, Inc., under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. The FDA also approved Foundation Medicine’s (FMI) FoundationOne CDx comprehensive genomic profiling (CGP) test as the registrational companion diagnostic (CDx) for Truseltiq.

Cholangiocarcinoma, or bile duct cancer, is rare and often detected in late stages when prognosis is poor and treatment options are limited. The parallel approvals of this therapy and CDx mean healthcare professionals will be able to identify cholangiocarcinoma patients with FGFR2 fusions and select rearrangements who may benefit from Truseltiq, another important step in helping more advanced cancer patients benefit from precision medicine, according to Foundation Medicine.

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Truseltiq is an orally administered, ATP-competitive, tyrosine kinase inhibitor of FGFR. In the pivotal trial of patients with advanced, unresectable CCA, an aggressive malignancy with poor prognosis, Truseltiq led to cases of tumor shrinkage. CCA is known to affect approximately 20,000 people in the United States and European Union each year and has a median five-year survival rate of only 9%.

“This is an important milestone for patients diagnosed with FGFR2-fusion-driven cholangiocarcinoma who have recurred after first-line therapy and are in need of targeted options for further treatment,” says Susan Moran, MD, MSCE, chief medical officer for QED. “Based on the efficacy seen to date, our team believes infigratinib possesses promise for a range of FGFR-driven conditions, including other cancers. We will continue to evaluate its safety and efficacy in these areas of unmet need.”