LEUKEMIAS

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.

During a <em>Targeted Oncology </em>live case-based peer perspectives presentation, Anthony Mato, MD, MSCE, explained to a group of physicians the diagnostic workup and treatment considerations and decisions he makes when seeing a patient with chronic lymphocytic leukemia in the clinic.

William G. Wierda, MD, PhD,&nbsp;discussed the emerging role of small molecule combinations and fixed-duration treatments in patients with relapsed/refractory CLL.

William G. Wierda, MD, PhD, discusses data surrounding the use of ibrutinib in combination with venetoclax as a treatment option for patients with newly diagnosed CLL as well as relapsed CLL.

Alexander E. Perl, MD, discusses results from the phase III ADMIRAL trial, which demonstrated a significant improvement in overall survival in patients with <em>FLT3</em>-mutated acute myeloid leukemia treated with the FLT3 inhibitor gilteritinib.

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.

Matthew S. Davids, MD, MMSc, discusses methods for choosing between frontline therapies for patients with newly diagnosed CLL and highlighted anticipated research in the field.

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.

A look back at all the&nbsp;FDA news&nbsp;that happened in March 2019, including several new approvals, a clinical hold, an orphan drug designation, and more.

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.

During a <em>Targeted Oncology </em>case-based peer perspectives program, Elias Jabbour, MD, discussed his clinical considerations for the management of chronic myeloid leukemia in chronic phase.&nbsp;Jabbour explained his treatment decisions during the live event based on a case scenario of a patient with CML-CP.

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.

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&nbsp;for the combination as a treatment for patients with&nbsp;previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions, according to an announcement from&nbsp;Genentech (Roche).

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

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;

Adding ibrutinib to&nbsp;CAR T-cell therapy led to improved responses in patients with relapsed/refractory chronic lymphocytic leukemia, according to preliminary findings presented at&nbsp;the 2019 Transplantation and Cellular Therapy Meetings.

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.