Iclusig Approved for Resistant or Intolerant Chronic-Phase CML
The sNDA approval is based on efficacy and safety data from the open-label phase 2 OPTIC trial and 5-year data from the phase 2 PACE trial.
The sNDA approval is based on efficacy and safety data from the open-label phase 2 OPTIC trial and 5-year data from the phase 2 PACE trial.
The approval was based on data from the BOSTON trial that assessed Xpovio in combination with bortezomib and dexamethasone in 402 adults with relapsed or refractory multiple myeloma who had received 1 to 3 prior therapies.
Investigators retrospectively assessed whether previous TKI therapy may affect response and survival outcomes in patients with relapsed or refractory acute myeloid leukemia.
Study results suggest that flotetuzumab demonstrates antileukemic activity in patients with primary induction failure and early-relapse acute myeloid leukemia.
A phase 3 trial showed a trend toward improved PFS with ixazomib plus lenalidomide and dexamethasone.
The phase 3 UNITY-CLL study showed prolonged PFS with the PI3K inhibitor plus anti-CD20 therapy combination.
Confirmed undetectable MRD after 12 cycles may result in treatment discontinuation.
The bispecific CAR-T therapy targets CD20 and CD19.
Response rates have improved as phase 1 studies shifted from chemotherapy to targeted agents for hematologic malignancies.
A fully human BCMA-directed CAR-T product showed clinical activity in patients with relapsed/refractory multiple myeloma.