The agent’s new drug application will be reviewed under the FDA’s Real Time Oncology Review pilot program and under Project Orbis.
The FDA accepted and granted priority review to the new drug application (NDA) for infigratinib to treat patients with cholangiocarcinoma, according to BridgeBio Pharma, Inc., an affiliate QED Therapeutics.
“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,” Neil Kumar, PhD, CEO and founder of BridgeBio, said in a press release.
The NDA is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, which is designed by the FDA’s Oncology Center of Excellence to expedite the delivery of safe and effective cancer treatments to patients. Moreover, the company will be submitting the agent for review in Australia and Canada under Project Orbis, another initiative from the FDA’s Oncology Center of Excellence, to allow for concurrent submission and review of oncology drugs among participating international regulatory agencies.
Infigratinib is an oral FGFR1-3 selective inhibitor aimed to treat patients with FGFR-driven conditions, including cholangiocarcinoma, urothelial carcinoma, and achondroplasia. FGFR2 genetic aberrations are present in approximately 15% to 20% of people who have cholangiocarcinoma – a disease with limited treatment options and a 5-year survival rate of only 9%.
BridgeBio Pharma, Inc. BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma. Published: December 1, 2020. https://bridgebio.com/news/bridgebio-pharma-and-affiliate-qed-therapeutics-announce-fda-acceptance-of-new-drug-application-for-infigratinib-for-the-treatment-of-cholangiocarcinoma. Accessed: December 1, 2020.