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BridgeBio Pharma and its subsidiary QED Therapeutics announced that the FDA has accepted a new drug application (NDA) for the oral FGFR1-3 selective inhibitor infigratinib for the treatment of patients with cholangiocarcinoma.
fda also granted this NDA priority review eligibility, while using the Real-Time Oncology Review (RTOR) pilot project for review.
, BridgeBio will file regulatory applications in Australia and Canada under the Orbis project.
is a cancer that occurs in the bile tubes of the liver and is a serious and often fatal disease that affects about 20,000 people in the United States and the European Union each year.
about 15%-20% of patients carry the FGFR2 gene variant.
currently, these patients have limited treatment options, with a five-year survival rate of only 9%.
Infigratinib is an ATP competitive, FGFR1-3 oral tyrosine kinase inhibitor that is being developed to treat patients with FGFR-driven diseases, including bile tube cancer, urinary cort skin cancer, and cartilage dysplase development (a disease of bone growth in children).
has teamed up with BridgeBio Pharma and QED Therapeutics to develop infigratinib in China and other Asian countries to treat cancers caused by mutations in the FGFR gene.
In China, this innovative therapy was approved last week for clinical trials in patients with localized advanced or metastatic stomach cancer or gastroesophageal adenocarcinoma accompanied by other FGFR gene mutations.
retrospective study published at this year's ANNUAL ASCO conference showed that infigratinib, a three-line or above monotherapy, had a median progression-free lifetime (PFS) of 6.8 months when treating patients with bile tube cancer that carried FGFR gene fusion.
, the average PFS for patients with bile tube cancer who had historically underwent second-line chemotherapy was 4.6 months.
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