CAR T-cell Therapy

Sofi-cel has received FDA breakthrough therapy designation for heavily pretreated patients with relapsed/refractory T-ALL and T-LBL.

Treatment with an allogeneic CD19-directed CAR natural killer–cell therapy led to an ongoing complete response at 15 months in Waldenstrom lymphoma.

The FDA will increase its flexibility on CMC requirements for cell and gene therapies to speed their development and better support BLA planning.

The first-in-class, CXCR4hi regulatory T-cell therapy CK0804 received orphan drug designation for patients with myelofibrosis.

Here is your Q1 2026 preview spotlighting 5 FDA decisions to watch, including upcoming PDUFAs for tabelecleucel, pembrolizumab, and more.

Obe-cel produced responses and low rates of high-grade CRS and ICANS in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

The top 5 OncLive TV videos of the week cover insights in leukemia, lung cancer, multiple myeloma, indolent systemic mastocytosis, and pancreatic cancer.

The FDA cleared narsoplimab for TA-TMA, an NDA seeking approval of bezuclastinib in nonadvanced systemic mastocytosis has been submitted, and more.

Here is your cheat sheet to all therapeutic options that were cleared by the FDA in December 2025 spanning tumor types.

Obe-cel was associated with lower rates of CRS and ICANS vs brexu-cel in relapsed or refractory acute lymphoblastic leukemia.

Experts reflect on pivotal data, emerging agents, and highly-anticipated trends spanning CML, CLL, B-cell lymphomas, and other hematologic malignancies.

Anito-cel showed deepening responses in patients with relapsed or refractory myeloma enrolled in the phase 2 iMMagine-1 study.

The top 5 OncLive TV videos of the week cover insights in acute myeloid leukemia, follicular lymphoma, multiple myeloma, and Ph+ B-ALL.

GLPG5101 produced responses and had a manageable safety profile in relapsed/refractory non-Hodgkin lymphoma, including mantle cell lymphoma.

AZD0120 CAR T therapy shows rapid, deep responses and manageable safety in R/R myeloma, with ultra-fast manufacturing and strong early durability.

In the CARTITUDE-4 trial, 80.5% of patients with standard-risk multiple myeloma were progression-free at 2.5 years after receiving cilta-cel.

The FDA approved liso-cel for relapsed/refractory MZL after 2 prior lines of therapy.

Hematology experts share the AML and ALL abstracts they’re most looking forward to seeing at the 2025 ASH Annual Meeting.

NICE has recommended obecabtegene autoleucel for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Liso-cel was approved in the EU for relapsed/refractory MCL after at least 2 lines of therapy, including a BTK inhibitor.

Sequential intracerebroventricular and intraventricular administration of CAR T-cell therapy was better tolerated in pediatric central nervous system tumors.

HER2-directed CAR T-cell therapy was safe in patients with brain/leptomeningeal metastases from HER2-positive breast cancer.

B7-H3–directed CAR T-cell therapy given intraventricularly was well tolerated and showed early efficacy signals in patients with recurrent glioblastoma.

Satri-cel displayed preliminary efficacy when used as adjuvant treatment in patients with pancreatic ductal adenocarcinoma.

The FDA granted RMAT designation to MB-105 for CD5-positive relapsed/refractory T-cell lymphoma.