LEUKEMIAS

Leukemia

A complete response letter has been issued to&nbsp;Daiichi Sankyo from the FDA, alerting the company to the reasons why the new drug application for quizartinib as a&nbsp;treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia would not be approved.&nbsp;

Patients with early-stage, asymptomatic, newly diagnosed chronic lymphocytic leukemia showed improved survival outcomes with ibrutinib monotherapy compared with placebo, according to results from phase III CLL12 study presented at the 2019 European Hematology Association Congress.<br /> &nbsp;

Combined treatment with ibrutinib and venetoclax was shown to be a safe and effective first-line oral regimen for high-risk and older patients with chronic lymphocytic leukemia, according to findings from an open-label phase II trial published recently in the<em> New England Journal of Medicine</em>.<br /> &nbsp;

Matthew S. Davids, MD, MMSc, discusses the significance of the findings from TRANSCEND CLL 004, a phase I/II trial investigating the CAR T-cell therapy lisocabtagene maraleucel in patients with relapsed or refractory chronic lymphocytic leukemia.

In an interview with <em>Targeted Oncology</em>, Naval G. Daver, MD, discussed the possibility of combination therapy in patients with AML. He highlights some of the most recent data to come out for this patient population, including for those harboring a <em>TP53</em> or <em>FLT3</em> mutation.

Jae H. Park, MD, discusses the current role and challenges in using CAR T-cell therapy in patients with relapsed or refractory acute myeloid leukemia. The 2 challenges now in this area are target selection and patient selection.

Patients with chronic lymphocytic leukemia showed high responses when given a combination of acalabrutinib and obinutuzumab, which targets BTK and the CD20 antigen. High response rates over 90% were seen across various settings of disease, according to the results of a small, preliminary trial.

According to the pivotal phase III CLL14 study presented during the 2019 American Society of Clinical Oncology Annual Meeting, venetoclax plus obinutuzumab demonstrated a lengthening in progression-free survival time for patients with previously untreated chronic lymphocytic leukemia compared with obinutuzumab plus chlorambucil. Trial results show that the chemotherapy-free combination reduced the risk for disease worsening or death by 65% compared with obinutuzumab plus chlorambucil.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.

A supplemental new drug application has been approved by the FDA&nbsp;to update the label for gilteritinib (Xospata) to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory <em>FLT3</em>-mutant AML.

John M. Burke, MD, reviews the treatment options he considers when treating a patient with chronic lymphocytic leukemia and the factors that sway his clinical decisions.

The combination of venetoclax (Venclexta) and obinutuzumab (Gazyva) has been approved by the FDA&nbsp;for the frontline treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, based on findings from the&nbsp;phase III CLL14 trial.

In an 8-3 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee has recommended against approving a new drug application for quizartinib for adult patients with relapsed/refractory&nbsp;FLT3-ITD&ndash;positive acute myeloid leukemia. The FDA is now scheduled to make a final decision on the application by&nbsp;August 25, 2019.

William G. Wierda, MD, PhD, discusses the take home message from the phase III MURANO trial that identified venetoclax plus rituximab as a new treatment option for patients with relapsed/refractory chronic lymphocytic leukemia.

Jacqueline C. Barrientos, MD, MS,&nbsp;discusses the emerging treatment options for patients with CLL, as well as some of the other strategies being looked at in clinical trials.

Alexander E. Perl, MD, discusses the latest advancements in the treatment landscape for patients with acute myeloid leukemia. These advances are driven by 2 factors: a better understanding of the biology of the disease and improving therapeutics to meet that understanding.

The phase III ASCEND trial has met its primary endpoint, as findings from the study showed that patients with previously treated chronic lymphocytic leukemia had a statistically significant and clinically meaningful improvement in PFS with acalabrutinib compared with the combination of rituximab and either idelalisib or bendamustine.

Elias Jabbour, MD, discusses the latest advancements in the treatment landscape for acute lymphocytic leukemia that are moving the paradigm away from chemotherapy.

In an interview with Targeted Oncology, Alexander E. Perl, MD,&nbsp;discussed the final results from the ADMIRAL trial and the impact these results have on practice.

Single-agent ivosidenib (Tibsovo) has received FDA approval for the first-line&nbsp;treatment of adult patients with <em>IDH1</em>-mutant acute myeloid leukemia, as detected by an FDA-approved test, who are &ge;75 years old or are ineligible to receive intensive chemotherapy.

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

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&nbsp;pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor will be discussed by the&nbsp;Oncologic Drugs Advisory Committee during a meeting on May 14, 2019, the FDA has announced.