HEMATOLOGY

The FDA has granted a breakthrough therapy designation to acalabrutinib monotherapy for the treatment of adult patients with chronic lymphocytic leukemia. The breakthrough designation was given based on the results of interim analyses from 2 phase III trials: ELEVATE-TN and ASCEND. 

The initial pilot study of CTL019 in heavily pretreated CD19-positive hematologic malignancies demonstrated the feasibility of CAR T-cell therapy in patients with CLL. A presentation at the 2019 American Society of Gene & Cell Therapy Annual Meeting reported 2 cases of chemotherapy-resistant CLL, with ongoing follow- up at 8 years showing persistence of CAR-engineered T cells and sustained remission, as determined by flow cytometry and deep sequencing of immunoglobulin H rearrangements. 

The American Society of Hematology has chosen Philip Greenberg, MD, to receive the 2019 E. Donnall Thomas Lecture and Prize for his work in immunotherapy.

Patients with relapsed or refractory acute myeloid leukemia typically have low response rates to chemotherapy. However, some subsets of patients, particularly those with targetable mutations, may have long-term survival when given a novel FLT3 inhibitor like gilteritinib, as seen in the ADMIRAL trial, says Mark J. Levis, MD, PhD.

Jorge Cortes, MD Cortes discussed frontline treatment options for patients with CML with <em>Targeted Oncology</em> ahead of a debate on optimal frontline regimens for chronic myeloid leukemia at the <em>3rd Annual</em> Live Medical Crossfire: Hematologic Malignancies, hosted by Physicians&rsquo; Education Resource.<br /> &nbsp;

In an interview with <em>Targeted Oncology</em>, Chong, a fellow at the University of Pennsylvania, discussed the 4-year follow-up data for CAR T cells in patients with DLBCL and FL. She also addressed the challenges that need to be overcome in order to give more patients access to this type of therapy.

Michael J. Mauro, MD, discusses how 4 FDA-approved frontline therapies are providing benefit to patients with chronic myeloid leukemia

In the phase I/II TRANSCEND CLL 004 study, chimeric antigen receptor T-cell therapy lisocabtagene maraleucel led to undetectable minimal residual disease in patients with relapsed/refractory chronic lymphocytic leukemia.

Take a look back on the FDA happenings, including approvals, fast track designations, priority reviews, and more from the month of July 2019.

The American Oncology Network, LLC will be acquiring a new practice from Ohio in August.

In an interview with&nbsp;Targeted Oncology, Richard M. Stone, MD, discussed the biggest controversies across a number of patient populations in AML. He also highlighted some areas of research he finds particularly exciting for the treatment of patients with AML.

In an interview with <em>Targeted Oncology</em>, Peter Martin, MD, assistant professor of medicine, Division of Hematology/Oncology, Weil Cornell Medicine, recounts physician crossfire discussions related to frontline MCL treatment and provides his own expert opinion on the subject.

The FDA has granted an orphan drug designation to MB-102, a CD123-directed CAR T-cell therapy, for the treatment of patients with acute myeloid leukemia.

PF-05280586, a biosimilar for rituximab, has been approved by the FDA for use as a single-agent or in combination with chemotherapy for the treatment of&nbsp;adult patients with CD20-positive B-cell non-Hodgkin lymphoma, or in combination with chemotherapy for patients with CD20-positive chronic lymphocytic leukemia.

Acute Myeloid Leukemia with Myelodysplastic-Related Cytogenetics

Over the past 2 years, the amount of FDA-approved frontline treatments for patients with acute myeloid leukemia have increased. These emergent treatments have caused a shift in the standard of care for patients with AML and inspiring analyses of regimens that researchers believe can improve outcomes for AML treatment.&nbsp;

Naval G. Daver, MD, discusses how the efficacy compares between first- and second-generation FLT3 inhibitors in acute myeloid leukemia.

In an interview with&nbsp;Targeted Oncology, Mark J. Levis, MD, PhD, discussed the findings from the follow-up analyses of the ADMIRAL trial that were presented at the 2019 ASCO Annual Meeting. He explained what these findings mean for the patient and what questions future research will aim to answer.

A single-arm, multicenter phase II trial held in China analyzed the Bruton&rsquo;s tyrosine kinase inhibitor zanubrutinib for treatment of patients with relapsed/refractory mantle cell lymphoma. Previously, the investigational BTK inhibitor gained a&nbsp;breakthrough&nbsp;designation&nbsp;from the&nbsp;FDA&nbsp;based on early results from the phase II trial that showed zanubrutinib to be highly active.<br /> &nbsp;

In an interview with&nbsp;<em>Targeted Oncology</em>, Susan Branford, PhD discussed the current role of NGS testing in hematologic malignancies. Following her presentation at the 2019 EHA Congress, she addressed how NGS can be incorporated more into the community practice and what challenges must be overcome in order to make this happen.