Lilly has begun submitting results from BRUIN CLL-313 and BRUIN CLL-314 studies to regulatory authorities with the goal of further expanding Jaypirca's label into earlier lines of therapy.
Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with a covalent BTK inhibitor ...Lilly is studying Jaypirca in CLL/SLL in multiple Phase 3 studies.