Data from the phase 3 BRUIN CLL-314 trial show a progression-free survival trend favoring pirtobrutinib compared with ibrutinib in patients with CLL/SLL.
AMPLIFY trial results form the basis of the submission, with venetoclax/acalabrutinib showing a PFS advantage vs chemoimmunotherapy in patients with CLL.
Ibrutinib tablets will become available at 140 mg, 280 mg, and 420 mg for patients with chronic lymphocytic leukemia and Waldenström macroglobulinemia.
Results from the phase 1b/2 FELIX trial demonstrated that obe-cel was efficacious and safe as therapy for relapsed/refractory B-cell precursor acute lymphoblastic leukemia.