Product receives orphan designation for use in HSCT

Hematopoietic stem cells
in the bone marrow
The US Food and Drug Administration (FDA) has granted orphan drug designation to dilanubicel (NLA101) for the reduction of morbidity and mortality associated with hematopoietic stem cell transplant (HSCT). Dilanubicel is a universal-donor, ex-vivo-expanded hematopoietic stem and progenitor cell product. Dilanubicel is intended to induce short-term hematopoiesis, which lasts until a patient’s immune system recovers. [Read Article]

Explaining enasidenib resistance in AML

Enasidenib (IDHIFA®)
Photo from Business Wire
New research helps explain enasidenib resistance among patients with IDH2-mutant acute myeloid leukemia (AML). Researchers found that leukemic cells stop responding to enasidenib when IDH2 clones develop additional mutations. This may mean that enasidenib will have to be combined with other drugs to prevent AML relapse, the researchers said. They reported their findings in Nature Medicine. [Read Article]

Investigators question utility of SFLCA

Won Sok Lee (left)
and Gurmukh Singh
Photo by Phil Jones,
Augusta University
Researchers are questioning the clinical usefulness of the serum free light chain assay (SFLCA) for patients with monoclonal gammopathies. The investigators found evidence suggesting that, about 25% of the time, SFLCA provides a negative κ/λ ratio in patients with lambda chain monoclonal gammopathies who have free homogenous lambda light chains detectable in their urine. [Read Article]