AGAVE-201 Data on Refractory cGvHD

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

The FDA has granted a rare pediatric disease designation to SLS009 for treating pediatric acute myeloid leukemia.

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.

The completion of the End of Phase 2 meeting for the phase 1B/2 trial of annamycin and cytarabine in acute myeloid leukemia has been announced.

During a Case-Based Roundtable® event, Amer Zeidan, MBBS, reviewed data for luspatercept-aamt for patients with low-risk myelodysplastic syndrome in the second article of a 2-part series.