LEUKEMIAS

Here's a look back on the FDA happenings for the month of August 2019, including FDA approvals, priority reviews, and breakthrough designations.

The addition of ixazomib to a combination of mitoxantrone, etoposide, and cytarabine demonstrated a promising rate of responses among patients with relapsed or refractory acute myeloid leukemia, according to the results of a phase I/II trial.

David Bond, MD, discusses 2 key findings from a recent study investigating the risk of developing a second cancer in patients with chronic lymphocytic leukemia treated with a BTK inhibitor.

In an interview with <em>Targeted Oncology</em>, Robert L. Redner, MD, highlighted the new agents available for the treatment of AML and some of the ongoing studies that could impact clinical practice.

In an interview with&nbsp;Targeted Oncology, Alessandra Tedeschi, MD, discussed the 5-year data she presented at the 2019 EHA Meeting for frontline ibrutinib as a treatment for patients with CLL. She also highlighted other research that may also benefit elderly patients with CLL, including the emerging combination of venetoclax and obinutuzumab.

In an interview with <em>Targeted Oncology, </em>James&nbsp;McCloskey, MD, explained the need for consideration of elderly patients when designing clinical trials for <em>IDH</em>-mutated AML and other considerations when treating this patient population.

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

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.

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.

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.

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.

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.

<em>FLT3</em> mutation analysis in laboratories has brought on reimbursement barriers in clinical oncology. Jordan Clark, chief commercial officer, Diaceutics, a diagnostic development and commercialization company, spoke to <em>Targeted Oncology</em> about the cause of reimbursement issues and how the problem affects all parties involved.

At 3 years of follow-up, the combination of acalabrutinib and obinutuzumab continued to show benefit in patients with both newly diagnosed chronic lymphocytic leukemia and relapsed or refractory disease.

Addressing the need for treatments that are more effective and less toxic for patients with relapsed or refractory chronic lymphocytic leukemia, Paolo Ghia, MD, of the Universita Vita-Salute San Raffaele, and other researchers conducted a phase III randomized, multicentric ASCEND study, testing acalabrutinib monotherapy in comparison with physician&rsquo;s choice of standard regimens in patients R/R CLL.

Significant activity was observed when ibrutinib was administered concurrently with CD19-directed CAR T-cell therapy compared with separately in patients with&nbsp;high-risk relapsed/refractory chronic lymphocytic leukemia who had progressed on or were intolerant of ibrutinib.&nbsp;Data presented at the 15th International Conference on Malignant Lymphoma show a high response rate with this concurrent treatment.&nbsp;