Hematology

The FDA has approved the CAR T-cell therapy brexucabtagene autoleucel (Tecartus; formerly KTE-X19) as a treatment for adult patients with relapsed/refractory mantle cell lymphoma (MCL).

To date, no FDA-approved options are available for patients under the age of 12 with SR-aGVHD in the United States, underscoring a great unmet need.

The FDA has accepted a supplemental new drug application (sNDA) seeking approval for selinexor (Xpovio) for the treatment of patients with multiple myeloma following at least 1 previous line of therapy.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.

The FDA has granted priority review to a new supplemental biologics license application for pembrolizumab monotherapy as a treatment for adult patients with relapsed/refractory classical Hodgkin lymphoma.

The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma, according to Cellectis, the manufacturer of the product.

The drug combination can be taken orally, at home.

The FDA has approved selinexor as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma, not otherwise specified, who have received ≥2 prior therapies.

Significant differences were seen between Hispanic and non-Hispanic white patients with hematological malignancies in Texas in terms of the age of diagnosis and long-term survival outcomes.

The FDA approved tazemetostat to treat relapsed/refractory follicular lymphoma in 2 different indications.

Given the recent use of genes to determine prognosis and treatment decisions in the field of hematology, it is important for providers to collaborate with geneticists.

The FDA expanded the approval of gemtuzumab ozogamicin (Mylotarg) to include newly diagnosed pediatric patients (1 month or older) with CD33-positive acute myeloid leukemia (AML).

Ruxolitinib (Jakafi) induced a strong, durable response across several subgroups of patients with steroid-refractory acute graft-versus-host disease.

Brad S. Kahl, MD, discusses the unique challenges that occur when treating patients with indolent non-Hodgkin lymphoma.

Long-term data presented at the 2020 ASCO Virtual Scientific Program demonstrated that acalabrutinib (Calquence) is safe and effective in patients with treatment-naïve chronic lymphocytic leukemia, supporting its use in the front line setting in this population.

Carfilzomib, lenalidomide, and dexamethasone did not demonstrate superior progression-free survival in newly diagnosed multiple myeloma.

The FDA has granted a Fast Track designation to CLR 131 for use as a treatment for patients with lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM) who have received at least 2 prior treatment regimens.

A United States population-based outcome analysis of real-world patients with myelofibrosis who had discontinued ruxolitinib (Jakafi) demonstrated an increase in morbidity burden and identified the risk factors of survival outcomes, according to John O. Mascarenhas, MD.

Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of selinexor (Xpovio) as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.

While aggressive lymphoma such as mantle cell lymphoma (MCL) typically end in relapse, precision medicine and cellular therapies are improving outcomes for patients, according to Michael Wang, MD.

The introduction of PET scans was a major advancement in the Hodgkin lymphoma treatment paradigm; however, some questions cannot be answered with that test, such as identifying which patients with PET-negative disease will relapse.

Over the last few weeks, the FDA was busy reviewing and approving new cancer treatments.

The FDA has added 3 months to the review period for a biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after at least 2 prior therapies. The extension will allow the agency to review additional data provided by Bristol Myers Squibb, the manufacturer of the anti-CD19 CAR T-cell therapy.

The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adults with newly diagnosed relapsed/refractory multiple myeloma.