NEW YORK – The US Food and Drug Administration on Friday granted accelerated approval to BridgeBio Pharma and Helsinn Group's infigratinib (Truseltiq) for use in FGFR2 fusion-positive, locally advanced or metastatic cholangiocarcinoma patients who have received prior treatment.
The agency simultaneously approved Foundation Medicine's FoundationOne CDx to identify advanced cholangiocarcinoma patients with FGFR2 fusions or rearrangements who are eligible to receive infigratinib.
The FDA made its decision after reviewing data from a Phase II trial involving around 100 previously treated patients, most of whom had stage IV disease. The objective response rate was 23 percent, and the median duration of response was five months.
QED Therapeutics, a subsidiary of Palo Alto, California-based BridgeBio, and Helsinn Group earlier this year entered into a licensing agreement to codevelop and co-commercialize infigratinib. Under the deal, BridgeBio and Helsinn Therapeutics, a unit of Helsinn Group, will equally share profits and losses from the drug in the US. Helsinn Group also has exclusive commercialization rights to infigratinib outside the US, except in China, Hong Kong, and Macau, where LianBio has those rights.
Helsinn Group has additional marketing applications for infigratinib under review in Australia and Canada through FDA's Project Orbis program, which allows sponsors to pursue drug approvals with regulatory agencies in multiple countries at once.
The FDA approval "provides a new therapy option for patients with a very low rate of survival," Helsinn Therapeutics CEO Paul Rittman said in a statement. "This new therapy has the potential to make a life-changing impact on patients with few treatment options, and Helsinn Therapeutics looks forward to working with BridgeBio to make it widely accessible to healthcare providers and patients in the US."
This is the second drug the FDA has approved for cholangiocarcinoma patients with FGFR2 fusions, which occur in between 9 percent and 14 percent of patients with the disease. Last year, the FDA approved pemigatinib (Incyte's Pemazyre) as a treatment for FGFR2 fusion-positive, previously treated, unresectable, locally advanced, or metastatic cholangiocarcinoma and FoundationOne CDx as the test to identify eligible patients.