New Immunotherapeutic Agents Broaden Treatment Options for Chronic Lymphocytic Leukemia

The CAR T-cell therapy UCART22 has been granted orphan drug designation and rare pediatric drug designation from the FDA for the treatment of acute lymphoblastic leukemia.

Current frontline treatment options for patients with chronic lymphocytic leukemia have grown over the past year, specifically with the approval of zanubrutinib.

The FDA has accepted the resubmitted application of remestemcel-L, a potential first-of-its-kind treatment for pediatric patients following stem cell transplants.

In season 4, episode 7 of Targeted Talks, Cyrus M. Khan, MD, discusses the latest FDA activity in the chronic lymphocytic leukemia space.

Following the report of a serious and unexpected grade 4 adverse effect, a partial clinical hold has been placed on the phase 1 trial evaluating seclidemstat with azacitidine in myelodysplastic syndrome and chronic myelomonocytic leukemia.

The FDA granted a fast track designation to DSP-5336 in relapsed/refractory AML with a KMT2A rearrangement or NPM1 mutation, showing promising results and safety in early trials.