Cholangiocarcinoma Foundation celebrates FDA’s Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma

On behalf of patients and families impacted by cholangiocarcinoma, the Cholangiocarcinoma Foundation (CCF) celebrates the December 1, 2020 FDA acceptance of Infigratinib. QED Therapeutics, is a subsidiary of BridgeBio, which is focused on precision medicine for FGFR-driven cancers. Infigratinib is an oral FGFR1-3 selective inhibitor, for individuals with cholangiocarcinoma, or cancer of the bile ducts.

This milestone in therapy development for cholangiocarcinoma marks one of what is hoped will be many approvals for the treatment of cholangiocarcinoma. In targeting a specific genetic mutation, FGFR2, which occurs in 15-20% of patients with cholangiocarcinoma, Infigratinib offers real hope to a small but significant subset of patients with this disease. “The approval of Infigratinib provides an exciting new treatment option for patients and will bring hope to those who typically face a difficult diagnosis and poor prognosis,” said Stacie Lindsey, Founder and CEO, Cholangiocarcinoma Foundation.

“This recent approval is evidence of the value of collaboration among and between industry and patient advocacy organizations,” said Jason Scott, Chair of the Board of Directors, Cholangiocarcinoma Foundation.

“We want to thank the patients, families, scientists, physicians and all others involved who helped us move this NDA forward. At BridgeBio we believe that every minute counts for patients and their families, and we are eager to help as many people suffering from cholangiocarcinoma as possible – as quickly as possible,” said BridgeBio CEO and Founder Neil Kumar, Ph.D.

BridgeBio will also submit for review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

“This recent approval is evidence of the value of collaboration among and between industry and patient advocacy organizations.”

Jason Scott, Chair of the Board of Directors, Cholangiocarcinoma Foundation.