AML

Ivosidenib (AG-120), an IDH1 inhibitor, demonstrated an objective response rate (ORR) of 41.6% in patients&nbsp;with relapsed/refractory&nbsp;<em>IDH1</em>-mutant acute myeloid leukemia (AML), according to findings from a single-arm phase I study.&nbsp;

The Leukemia &amp; Lymphoma Society (LLS) has awarded Barbara Savoldo, MD, PhD, with a $600,000, 3-year grant in support of her promising research into a CAR T-cell treatment with a &ldquo;safety switch&rdquo; that could alleviate potential side effects for patients with acute lymphoblastic leukemia being treated with the immunotherapy.

The American Society of Hematology has announced that James R. Downing, MD, of St. Jude Children&rsquo;s Research Hospital will be awarded the 2017 E. Donnall Thomas Lecture and Prize for his discoveries related to the hematopathology and molecular biology of childhood leukemia.

Richard M. Stone, MD, director of the Adult Leukemia Program, Dana-Farber Cancer Institute, and professor of medicine, Harvard Medical School, discusses monitoring minimal residual disease (MRD) in patients with acute myeloid leukemia (AML).

Although preclinical data are promising, there are many clinical challenges in developing CAR T-cell therapy in acute myeloid leukemia.

Gilteritinib has been granted Fast Track designation by the FDA for adult patients with&nbsp;FLT3 mutation-positive relapsed/refractory acute myeloid leukemia, according to Tokyo-based Astellas Pharma.

Midostaurin has received approval from the European Commission as a treatment for adults with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia and advanced systemic mastocytosis, including aggressive systemic mastocytosis, SM with associated hematological neoplasm, and mast cell leukemia.

Understanding of the role of BCL-2 in acute myeloid leukemia (AML) continues to evolve, even as BCL-2&ndash;targeted therapy improves outcomes in the disease, AML specialist Daniel Pollyea, MD, MS said at the 2017 Society of Hematologic Oncology Annual Meeting in Houston, Texas.

Harry Erba, MD, PhD, professor of medicine, director, University of Alabama (UAB) Hematologic Malignancy Program, UAB School of Medicine, discusses using MRD to guide therapy in acute myeloid leukemia (AML).

Updated findings from the registration trial of the first FDA-approved CAR T-cell therapy showed that 83% of patients with acute lymphoblastic lymphoma achieved complete remission with complete or incomplete hematologic recovery, as reported at the 2017 Society of Hematologic Oncology Annual Meeting.<br /> &nbsp;

Results from a recent retrospective study published in the<em> Journal of Clinical Oncology</em>^&nbsp;revealed hospice enrollment is low and use of aggressive treatment is high for elderly patients with acute myeloid leukemia.

Eunice Wang, MD, discusses a study examining the biology of newly diagnosed patients with <em>FLT3</em>-positive acute myeloid leukemia who achieved a response to the FLT3 TKI crenolanib combined with chemotherapy.

Mutations in FLT3 have long been recognized in a portion of patients with acute myeloid leukemia. Yet it took more than 15 years until an agent targeting FLT3 mutations came to fruition with the FDA approval of midostaurin in April 2017, marking about 40 years since the last new agent was approved to treat patients with AML.

CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, has been approved by the FDA for adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), based on an improvement in overall survival (OS) in a phase III study.

Enasidenib (Idhifa) has been approved by the FDA as a treatment for patients with relapsed or refractory <em>IDH2</em>-mutated acute myeloid leukemia (AML), based on findings from a phase I/II study. A companion diagnostic, the RealTime IDH2 Assay, was also approved for the detection of the <em>IDH2</em> mutation.

The FDA has granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-na&iuml;ve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.

Midostaurin (Rydapt) has been recommended for approval by the European Medicines Agency&#39;s Committee for Medicinal Products for Human Use (CHMP) to treat adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation&ndash;positive.

The Oncologic Drugs Advisory Committee voted 10-0 today to recommend approval of a biologics license application for tisagenlecleucel for the treatment of patients aged 25 or younger with relapsed/refractory B-cell acute lymphoblastic leukemia.

In a 6-1 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee (ODAC) voted in favor of approving gemtuzumab ozogamicin in combination with daunorubicin and cytarabine for the treatment of patients with newly-diagnosed CD33-positive acute myeloid leukemia.

Blinatumomab (Blincyto) has been granted a full approval by the FDA as a treatment for adults and children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, regardless of Philadelphia chromosome status.

Eytan M. Stein, MD, internist, hematologic oncologist, Memorial Sloan Kettering Cancer Center, discusses the results of a phase I dose escalation and expansion study of enasidenib in mutant <em>IDH-2</em> relapsed or refractory acute myeloid leukemia (AML) during the 2017 ASCO Annual Meeting.

A new drug application from Jazz Pharmaceuticals has been accepted by the FDA for a novel CPX-351 injection (Vyxeos) for the treatment of acute myeloid leukemia.

Gail J. Roboz, MD, discusses&nbsp;the recent FDA approval of midostaurin and what else is emerging in the treatment landscape in AML.

Richard M. Stone, MD,&nbsp;discusses the impact that midostaurin could have for patients with AML, as well as ongoing research with the agent.

Midostaurin (Rydapt) has been approved by the FDA for the treatment of adult patients with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia (AML) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.

The investigational tyrosine kinase inhibitor quizartinib is extremely promising as a monotherapy for patients with <em>FLT3-ITD&ndash;</em>positive relapsed acute myeloid leukemia.

Patients with hematologic malignancies who receive a hematopoietic stem cell transplant (HSCT) still risk treatment failure through relapse. As part of a conditioning regimen prior to allogenic HSCT, strategies are emerging to improve HSCT outcomes by reducing the risk of relapse. Several of these conditioning regimens were reviewed during a satellite symposium to the 2017 BMT Tandem Meetings.

Richard M. Stone, MD, discusses what is currently understood regarding the genetic landscape in acute myeloid leukemia (AML).

Andrew Wei, MBBS, PhD, discusses&nbsp;a study which explored the safety and efficacy of the novel BCL-2 inhibitor venetoclax in combination with low-dose cytarabine chemotherapy for treatment-na&iuml;ve patients over the age of 65 with AML.

Mutations in isocitrate dehydrogenase 1 and 2 (<em>IDH1/2</em>) are not the mutations commonly found in cancer cells, according to a presentation from the 2017 AACR Annual Meeting.