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New Drug: Infigratinib for FGFR2+ cholangiocarcinoma

New Drug: Infigratinib for FGFR2+ cholangiocarcinoma
  • Single-arm phase II study (BGJ398)
  • Advanced/metastatic cholangiocarcinoma with FGFR2 fusions/rearrangements with progression on >= 1 line
  • Infigratinib 125 mg PO daily (21/28 days)
  • ORR: 23.1% [15.6%-32.2%]
  • Median DoR: 5.0 mos (range 0.9 – 19.1 mos)
  • Median PFS: 7.3 mos [5.6-7.6 mos]
  • Grade >=3 AEs: Stomatitis (15%), hyponatremia (13%), hypophosphatemia (13%), central serous retinopathy (1%)

J Clin Oncol 2021;39(3):suppl 265-265

Javle MM, et al. Final results from a phase II study of infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, in patients with previously treated advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement

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