Benzinga | May 28, 2021 02:32PM EDT

BridgeBio Pharma's Affiliate QED Therapeutics And Partner Helsinn Group Announce FDA Approval Of TRUSELTIQ For Patients With Cholangiocarcinoma

Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement

BridgeBio, through its affiliate QED ("BridgeBio"), and Helsinn will co-commercialize TRUSELTIQ in the U.S.

TRUSELTIQ is BridgeBio's first FDA approved therapeutic in oncology and second approved therapeutic this year

PALO ALTO, Calif. and LUGANO, Switzerland, May 28, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (NASDAQ:BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ(tm) (infigratinib) 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. 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%.1