HEMATOLOGY

A partial clinical hold has been placed on all clinical trials examining venetoclax in multiple myeloma, according to AbbVie, co-developer of the BCL-2 inhibitor with Genentech. This hold, placed by the FDA, halts enrollment of new patients on the studies.

Following a recommendation from the Oncologic Drugs Advisory Committee against the accelerated approval of selinexor for the treatment of patients with penta-refractory multiple myeloma, the FDA has added 3 months to the review period for the new drug application, making the new action date July 6, 2019.

The healthcare community is still awaiting a response from the Centers for Medicare & Medicaid Services to the opposition of the agency’s proposal to substantially revise the Medicare Part D protected drug classes.

In a review of over 300 hematopoietic cell transplantation cases, thrombotic microangiopathy occurred in as many as 36% of patients and significantly raised the risk of related death, according to findings reported at the 2019 Transplantation and Cellular Therapy Meetings.

David Miklos, MD, discusses his advice for community oncologists treating patients with diffuse large B-cell lymphoma.

Overtreating men 70 years or older with prostate cancer cost Medicare more than $1.2 billion from 2004 to 2007, according to the results of a retrospective study using the Surveillance, Epidemiology, and End Results–Medicare linked database.

Jacqueline C. Barrientos, MD, MS, discusses the role of acalabrutinib, a second-generation BTK inhibitor, that is available for patients with chronic lymphocytic leukemia, but not yet approved.

Genomic testing could increasingly be utilized to guide treatment decisions for Veteran patients with cancer. Two recent announcements confirm an emerging focus from Veterans Affairs on genetic testing that provides more informed and tailored cancer care for US Veterans.

Sagar Lonial, MD, discussed some of the emerging agents for the treatment of patients with late relapse in multiple myeloma.

Eytan M. Stein, MD, sheds light on the current treatment landscape of AML and underscored the importance of molecular monitoring. In addition, he highlights where the field of AML is headed.

The combination regimen of venetoclax and obinutuzumab is seeking FDA approval; a supplemental new drug application has been submitted to the FDA for the combination as a treatment for patients with previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions, according to an announcement from Genentech (Roche).

Natalie S. Grover, MD, discusses the potential role of CD30-specific chimeric antigen receptor T cells in patients with relapsed/refractory Hodgkin Lymphoma.

Jacqueline C. Barrientos, MD, MS, discusses emerging agents and combinations in CLL based on recent trial data.

Sangmin Lee, MD, discusses a potential way to overcome resistance to venetoclax in acute myeloid leukemia.

Richard M. Stone, MD, discusses emerging agents and combinations for older patients with AML, along with his preferences for treatment.

A look back at all the FDA news in oncology from the month of February 2019, including several new approvals, priority review designations, and an orphan drug desgination.

In an interview with&nbsp;<em>Targeted Oncology&nbsp;</em>during the 2018 ASH Annual Meeting, Elizabeth Lihua Budde, MD, PhD, discussed the results seen from this trial for patients with FL and DLBCL. She shared plans for the next steps and how this treatment may impact the patient population.

In an interview with Targeted Oncology, Nathan H. Fowler, MD, discussed the current research for the treatment landscape of relapsed/refractory follicular lymphoma, including 3 clinical trials at MD Anderson that are currently accruing patients with this disease.

In an interview with&nbsp;<em>Targeted Oncology,&nbsp;</em>Stephen Douglas Smith, MD, discussed recent advancements in FL, new treatments currently being evaluated in clinical trials, and the challenges that still exist within this space.

Elizabeth Lihua Budde, MD, PhD, discusses how the phase I/Ib clinical trial for mosunetuzumab in patients with follicular lymphoma is different than other clinical trials.

Based on data from the phase III AUGMENT trial, a supplemental new drug application for the&nbsp;R²&nbsp;regimen of lenalidomide plus rituximab has been granted a priority review designation by the FDA&nbsp;as a therapy for patients with previously treated follicular lymphoma and marginal zone lymphoma.

In an interview with <em>Targeted Oncology&nbsp;</em>during the 2019 TCT meeting, Frederick L. Locke, MD, discusses the optimal management of CAR T-cell therapy-related adverse events.

Based on data from an ongoing preliminary trial, CD30-targeting chimeric antigen receptor T cells are safe and active in the treatment of patients with relapsed/refractory Hodgkin lymphoma.

According to findings from the phase III COLUMBA trial in patients with relapsed/refractory multiple myeloma, a&nbsp;subcutaneous formulation of daratumumab &nbsp;is noninferior in terms of inefficacy and pharmacokinetics to the standard&nbsp;intravenous daratumumab.

All but 1 of the first 19 patients with relapsed/refractory AML randomized to receive iodine-131 apamistamab had a complete response and went on to have successful engraftment of allogeneic hematopoietic stem cell transplant,&nbsp;according to preliminary results from the ongoing, randomized, phase III SIERRA trial that were presented at the 2019 Transplantation and Cellular Therapy Meetings.&nbsp;