Tags : Unresectable

Incyte’s Pemazyre (pemigatinib) Receives the US FDA’s Approval as the

Shots: The approval is based on P-II FIGHT-202 (NCT02924376) study which involves assessing of Pemazyre (13.5 mg, qd) in adults with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement The study has three cohorts: Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no […]Read More

Seattle’s TUKYSA (tucatinib) Receives the US FDA’s Approval for Advanced

Shots: The approval is based on HER2CLIMB study assessing TUKYSA in combination with trastuzumab and capecitabine vs trastuzumab & capecitabine monothx in ratio (2:1) in 612 patients with 1L+ Anti-HER2 therapies in the metastatic setting either monothx or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1) The study resulted in 46% reduction in the risk […]Read More

Merck and Eisai’s Dual Regimen Receives the US FDA’s Breakthrough

Shots: The BT designation is based on P-Ib KEYNOTE-524/Study 116 trial assessing Keytruda (200mg, IV, q3w) + Lenvima (12mg/day for patients weighing ≥60kg, and 8mg/day for patients weighing <60kg) in patients with unresectable HCC not amenable to locoregional treatment The FDA’s BT designation intended to expedite development and review of medicines for serious or life-threatening […]Read More