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.
Hematologic Cancers
Xpovio Multiple Myeloma Indication Expanded
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.
Does Prior TKI Therapy Affect Outcomes in R/R AML Treated With Gilteritinib?
Investigators retrospectively assessed whether previous TKI therapy may affect response and survival outcomes in patients with relapsed or refractory acute myeloid leukemia.
Antileukemic Activity Seen With Flotetuzumab in Primary Induction Failure, Early-Relapse AML
Study results suggest that flotetuzumab demonstrates antileukemic activity in patients with primary induction failure and early-relapse acute myeloid leukemia.
Ixazomib Plus Lenalidomide and Dexamethasone for Newly Diagnosed MM
A phase 3 trial showed a trend toward improved PFS with ixazomib plus lenalidomide and dexamethasone.
Umbralisib Plus Ublituximab Improved PFS vs Chemoimmunotherapy in CLL
The phase 3 UNITY-CLL study showed prolonged PFS with the PI3K inhibitor plus anti-CD20 therapy combination.
Fixed Duration Ibrutinib-Venetoclax for CLL Resulted in High Rate of Undetectable MRD
Confirmed undetectable MRD after 12 cycles may result in treatment discontinuation.
Bispecific CAR-T Therapy Found to Have Promising Efficacy in Older Patients With R/R B-Cell NHL
The bispecific CAR-T therapy targets CD20 and CD19.
Response Rates in Phase 1 Studies of Hematologic Malignancies Improved Over Time
Response rates have improved as phase 1 studies shifted from chemotherapy to targeted agents for hematologic malignancies.
Fully Human BCMA-Directed CAR-T Shows High Response Rate in Myeloma
A fully human BCMA-directed CAR-T product showed clinical activity in patients with relapsed/refractory multiple myeloma.
