Category: Biliary Tract Cancer
The FDA has kicked off a priority review of AstraZeneca’s checkpoint inhibitor Imfinzi for biliary tract cancer (BTC), setting up what could be approval for an immunotherapy for the group of rare and aggressive gastrointestinal tumours. The six-month review means that PD-L1 inhibitor Imfinzi (durvalumab) could get a verdict from the US regulator in the […]
AstraZeneca’s checkpoint inhibitor Imfinzi has become the first cancer immunotherapy to improve survival in previously-untreated patients with biliary tract cancer (BTC), a rare and aggressive group of gastro-intestinal tumours. In the TOPAZ-1 trial, PD-L1 inhibitor Imfinzi (durvalumab) added to standard chemotherapy extended overall survival compared to chemo alone, raising the hope of a new option […]
GlaxoSmithKline’s big gamble on Merck KGaA’s bintrafusp alfa has gone from bad to worse, after the drug failed yet another mid-stage trial. The latest disappointment has come from the phase 2 [email protected] BTC 055 study of the drug alongside chemotherapy as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer (BTC), […]
Shots: The approval is based on the P-II FIGHT-202 study that involves assessing Pemazyre (13.5mg, qd, on a 21-day cycle) in adults aged ≥18yrs. with previously treated, LA/m- cholangiocarcinoma with documented FGFR2 fusion or rearrangement The study has three cohorts: Cohort A (FGFR2 fusions), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR […]