On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30 ...
On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30 ...
Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated safety...
Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81%...
- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK...
- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors - - Selective JAK V617F inhibitor,...
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per...
-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria –...
Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months (HR=0.50, CI:...
Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS...