LEUKEMIAS

A new drug application for enasidenib has been granted a priority review by the FDA as a treatment for patients with relapsed or refractory <em>IDH2</em>-mutated acute myeloid leukemia.

The anti-CD22 antibody-drug conjugate inotuzumab ozogamicin has been granted a priority review designation&nbsp;by the FDA for the treatment of patients with relapsed or refractory ALL.

A full regulatory approval is being sought for blinatumomab as a treatment for patients with Philadelphia chromosome-negative relapsed/refractory B-precursor ALL.

Philadelphia chromosome Ph&ndash;like acute lymphoblastic leukemia accounts for more than 20% of all adult patients with ALL and is associated with a poor outcome, according to findings published in the Journal of Clinical Oncology.

Lead study author Jennifer A. Woyach, MD, discusses a phase II trial of MOR208, which includes cohorts of patients with relapsed/refractory CLL, treatment-na&iuml;ve disease, Richter&rsquo;s transformation, and those with CLL who have been treated with ibrutinib.

Several phase I trials of vadastuximab talirine in acute myeloid leukemia have been placed on hold by the FDA, according to Seattle Genetics, the manufacturer of the antibody-drug conjugate.

Jennifer Woyach, MD, associate professor, Ohio State University, discusses a study combining MOR208 with Lenalidomide for the treatment of chronic lymphocytic leukemia (CLL).&nbsp;

According to recent study findings, the investigational BTK inhibitor acalabrutinib was shown to be well-tolerated and effective in patients with chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) who display intolerance to ibrutinib (Imbruvica).

The Society for Immunotherapy of Cancer (SITC) has announced that Paul M. Sondel, MD, PhD, will receive the 2017 Richard V. Smalley, MD Memorial Lectureship Award.

Treatment with the BTK inhibitor BGB-3111 had an objective response rate (ORR) of 96% for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL).

Combining the PI3 kinase inhibitor TGR-1202 and ibrutinib (Imbruvica) for patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) demonstrated a high response rate without dose-limiting toxicities (DLTs).

The CAR T-cell therapy CTL019 demonstrated an 82% complete remission or CR with incomplete blood count recovery rate for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

With treatment for newly diagnosed acute myeloid leukemia remaining essentially unchanged over the last 4 decades, researchers are hopeful that the addition of the investigational agent vadastuximab talirine to standard 7+3 induction therapy may improve survival for these patients.&nbsp;

TKIs can safely be stopped or dose-reduced without jeopardizing long-term outcomes for select patients with chronic myeloid leukemia who have obtained a major molecular response.

Anti-CD22 chimeric antigen receptor (CAR) T-cell therapy induced an 80% complete remission rate among children and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia.

Miguel Perales, MD, deputy chief, Adult Bone Marrow Transplant Service, and director, Adult Bone Marrow Transplantation Fellowship Program, gives an overview of the PROGRESS II trial in&nbsp;acute leukemia and myelodysplastic syndrome during the ASH Annual Meeting.

The FDA has granted a full approval and label update to ponatinib (Iclusig) for patients with chronic phase (CP), accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

The FDA has granted a priority review to the multikinase inhibitor midostaurin as a treatment for patients with newly-diagnosed&nbsp;<em>FLT3</em>-mutated acute myeloid leukemia or advanced systemic mastocytosis.

Immune checkpoint inhibitor development is progressing as treatments for patients with acute myeloid leukemia and myelodysplastic syndrome, with a number of studies currently assessing new combination strategies.

Steven Coutre, MD,&nbsp;professor of medicine, Stanford University School of Medicine, discusses the benefits and drawbacks of the different frontline treatment options for&nbsp;chronic lymphocytic leukemia (CLL).

Alessandra Ferrajoli, MD,&nbsp;discusses the challenge with secondary malignancies in patients with CLL.

William G. Wierda, MD, PhD, discusses&nbsp;provided his expert insight on the frontline treatment of patients with CLL.

Richard R. Furman, MD emphasizes that physicians should follow their best independent judgment regarding therapy selection in CLL, regardless of FDA approval.

The positive opinion for the BCL-2 inhibitor has been sent to the European Commission, which usually issues its final approval decision within 2 to 3 months of the CHMP recommendation.

Steve Coutre, MD, discusses how he determines which CLL treatment option is best for which patient, the advantage of treating patients with ibrutinib over chemoimmunotherapy, and new oral agents currently being investigated in the space.