Tags : Cholangiocarcinoma

Regulatory

Taiho Oncology’s Futibatinib (TAS-120) Receives the US FDA’s Breakthrough Therapy

Shots: The designation is based on efficacy & safety results from the P-II FOENIX-CCA2 study involves assessing futibatinib (TAS-120) in patients with advanced cholangiocarcinoma. The findings will be presented at AACR 2021 The preliminary clinical evidence showed improvement on at least one clinical EPs over available therapy Futibatinib (TAS-120, PO) is a covalently-binding FGFR inhibitor […]Read More

Regulatory

Incyte Reports Acceptance and Priority Review of NDA for Pemigatinib

Shots: The NDA submission is based on P-II FIGHT-202 study assessing Pemigatinib in patients aged ≥ 18yrs. with previously treated, LA/metastatic cholangiocarcinoma with documented FGF/FGFR status The P-II FIGHT-202 study resulted in 36% ORR, 7.5mos. mDOR with a median follow-up of 15 mos. in patients harboring FGFR2 fusions or rearrangements. AEs are manageable and consistent […]Read More

Pharma

Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial

Shots: The P-II FIGHT-202 (NCT02924376) study involves assessing of pemigatinib (13.5 mg, qd) as monothx in adults patients previously treated, LA or metastatic cholangiocarcinoma with documented FGF/FGFR status divided into 3 cohorts: Cohort A (N=107, FGFR2 fusions or rearrangements), Cohort B (N=20, other FGF/FGFR genetic alterations) or Cohort C (N=18, no FGF/FGFR genetic alterations)   […]Read More