Hematology

Following a phase 1b trial, the potent and selective dual inhibitor of IRAK1 and IRAK4 received fast track designation for the treatment of patients with lower-risk myelodysplastic syndrome.

An expert discusses the FDA approval of obecabtagene autoleucel—the only CAR T-cell therapy given via split dosing for patients with ALL.

Anitocabtagene autoleucel may be a promising CAR-T cell therapy option for patients with relapsed/refractory myeloma.

Brexu-cel is effective in treating patients with relapsed/refractory B-cell acute lymphoblastic leukemia, real-world data shows.

An indirect comparison found that cilta-cel may be better than standard of care for patients with lenalidomise-refractory relapsed/refractory myeloma.

Here’s a roundup of FDA approvals in the oncology space from October 2024.

The FDA granted an accelerated approval to asciminib for newly diagnosed Ph+ chronic myeloid leukemia in the chronic phase.

Among evaluable patients with Waldenström macroglobulinemia, the ORR was 77.8% with NX-5948.

Pharmacologic strategies may be able to prevent abnormal uterine bleeding in patients undergoing stem cell transplant.

Nivolumab plus AVD outperformed brentuximab vedotin plus AVD in patients with advanced-stage classical Hodgkin lymphoma.

Asciminib is a promising agent for frontline chronic myeloid leukemia, Jorge Cortes, MD, explained.

A poll of experts revealed that few are utilizing talquetamab for patients with pretreated relapsed/refractory myeloma.

An analysis of 16 studies showed that CAR T-cell therapy is safe and effective for relapsed/refractory mantle cell lymphoma.

NT-17, a long-acting IL-7 agent, enhances CAR T-cell factors associated with efficacy in patients with relapsed/refractory DLBCL when administered 21 days post-CAR T infusion.

P-BCMA-ALLO1 elicited high response rates and a manageable safety profile in heavily pretreated, relapsed/refractory multiple myeloma.

The FDA granted a priority review to acalabrutinib for the treatment of previously untreated adults with mantle cell lymphoma.

Follow-up from the CARTITUDE-4 trial showed that cilta-cel improved survival over standard of care in pretreated myeloma.

Cilta-cel led to high response rates and a promising safety profile in a real-world population of patients with relapsed/refractory myeloma.

Belantamab mafodotin plus KRd had a a manageable safety profile and deep responses in pretreated multiple myeloma.

Older adults with acute myeloid leukemia treated with anthracyclines tended to live longer, but also had more time spent in the hospital compared with those treated with HMAs.

Belantamab plus VRd led to promising outcomes in newly diagnosed transplant-eligible myeloma, study results showed.

The use of ruxolitinib presented improved rates of skin/joint responses, cGVHD responses, patient-reports, low NRM, and high FFS in patients with refractory sclerotic cGVHD.

GC012F, a BCMA/CD19–targeted CAR T-cell therapy, safely produced favorable outcomes in patients with newly diagnosed multiple myeloma after induction therapy.

The FDA approved Boruzu, a new presentation of bortezomib, for subcutaneous or intravenous administration in patients with multiple myeloma and mantle cell lymphoma.

Pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia are receiving tisagenlecleucel in earlier lines of therapy.

Throughout August, the FDA approved drugs for the treatment of diseases including non-small cell lung cancer, cutaneous T-cell lymphoma, astrocytoma/oligodendroglioma, and endometrial cancer.

Minimal residual disease status was linked to progression-free survival in patients with chronic lymphocytic leukemia in the first-line treatment setting and with time-limited therapy.

A phase 2 study reveals impactful objective response rates with manageable adverse events in patients with relapsed/refractory follicular lymphoma treated with odronextamab.

A CRL has been issued by the FDA to the biologics license application seeking approval of linvoseltamab to treat some patients with multiple myeloma.