HEMATOLOGY

A look back at all the FDA news that happened in the month of April 2019, including several new approvals, a priority review, breakthrough designation, and more.

Treatment with tagraxofusp led to a high rate of responses in patients with blastic plasmacytoid dendritic cell neoplasm regardless of whether patients had received prior treatment or not, findings from a nonrandomized phase II trial demonstrated.

CLL Case Review: IgHV-Unmutated Therapy Options

The first patient has been dosed in a phase III clinical trial investigating the addition of uproleselan (GMI-1271) to standard 7+3 chemotherapy in older patients with previously untreated acute myeloid leukemia.

A new drug application seeking the approval of pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor will be discussed by the Oncologic Drugs Advisory Committee during a meeting on May 14, 2019, the FDA has announced.

During a <em>Targeted Oncology </em>live case-based peer perspectives presentation, Anthony Mato, MD, MSCE, explained to a group of physicians the diagnostic workup and treatment considerations and decisions he makes when seeing a patient with chronic lymphocytic leukemia in the clinic.

High-Risk IgVH-Unmutated Chronic Lymphocytic Leukemia

The FDA has granted a fast track designation and an orphan drug designation to APR-246, a novel agent targeting p53 for the treatment of patients with myelodysplastic syndromes.

William G. Wierda, MD, PhD,&nbsp;discussed the emerging role of small molecule combinations and fixed-duration treatments in patients with relapsed/refractory CLL.

William G. Wierda, MD, PhD, discusses data surrounding the use of ibrutinib in combination with venetoclax as a treatment option for patients with newly diagnosed CLL as well as relapsed CLL.

Alexander E. Perl, MD, discusses results from the phase III ADMIRAL trial, which demonstrated a significant improvement in overall survival in patients with <em>FLT3</em>-mutated acute myeloid leukemia treated with the FLT3 inhibitor gilteritinib.

Richard M. Stone, MD,&nbsp;discusses the emerging agents for older patients with AML, as well as the importance of patient assessment and the identification of select mutations.

Nathan H. Fowler, MD, discusses the latest addition to the treatment landscape for marginal zone lymphoma.

Naval G. Daver, MD, discusses treatment options and the data these options are based off of for the management of acute myeloid leukemia, based on a case scenario of a patient with <em>FLT3 </em>internal tandem duplication &ndash;positive acute myeloid leukemia.

Matthew S. Davids, MD, MMSc, discusses methods for choosing between frontline therapies for patients with newly diagnosed CLL and highlighted anticipated research in the field.