AML

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;

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.

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 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.

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.

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.

Richard M. Stone, MD,&nbsp;discusses the emerging agents for older patients with AML, as well as the importance of patient assessment and the identification of select mutations.

Naval G. Daver, MD, discusses treatment options and the data these options are based off of for the management of acute myeloid leukemia, based on a case scenario of a patient with <em>FLT3 </em>internal tandem duplication &ndash;positive acute myeloid leukemia.

The review period on the new drug application for quizartinib as a treatment for adult patients with&nbsp;relapsed/refractory <em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia has been extended by the FDA by 3 months.&nbsp;This provides the FDA with additional time to review more data supplied by&nbsp;Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.

Overall survival was significantly improved in&nbsp;patients with relapsed/refractory <em>FLT3</em> mutation&ndash;positive acute myeloid leukemia who were treated with the FLT3 inhibitor gilteritinib, according to&nbsp;updated findings presented during the 2019 AACR Annual Meeting.

During a <em>Targeted Oncology</em> live case-based peer perspectives program, B. Douglas Smith, MD, discussed his clinical consideration for the management of acute myeloid leukemia. Smith explained his treatment decisions during the dinner event in 2 case scenarios of patients with AML.

The FDA has granted ivosidenib plus azacitidine a breakthrough therapy designation for the treatment of newly diagnosed patients with acute myeloid leukemia who harbor an <em>IDH1 </em>mutation and are &ge;75 years old or have comorbidities that would prevent them from receiving intensive induction chemotherapy.

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.

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.

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

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;

A supplemental new drug application for ivosidenib has been granted a priority review designation by the FDA&nbsp;for the frontline treatment of patients <em>IDH1</em>-mutant acute myeloid leukemia who are ineligible for standard chemotherapy, according to&nbsp;Agios, the manufacturer of ivosidenib.

The first attempt to quantify therapy-related myelodysplastic syndrome or acute myeloid leukemia in the era of widespread platinum-based chemotherapy has found that tMDS/AML risks were statistically significantly elevated after chemotherapy for 22 of 23 solid cancers, according to a new study in <em>JAMA Oncology.</em>