AML

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.

Sudipto Mukherjee, MD, assistant staff, Gaussig Cancer Institute, Cleveland Clinic, discusses a study exploring eltrombopag to enhance platelet count recovery in elderly patients with acute myeloid leukemia (AML).

The researchers discuss the rationale for checkpoint-based therapies including antibodies to PD-1/PD-L1 and CTLA-4, an overview of clinical experience with these agents, and future considerations and combinations of these agents.

Clinical holds on several phase I trials of vadastuximab talirine in acute myeloid leukemia have been lifted by the FDA.

A new drug application for enasidenib has been granted a priority review by the FDA as a treatment for patients with relapsed or refractory <em>IDH2</em>-mutated acute myeloid leukemia.

Several phase I trials of vadastuximab talirine in acute myeloid leukemia have been placed on hold by the FDA, according to Seattle Genetics, the manufacturer of the antibody-drug conjugate.

The Society for Immunotherapy of Cancer (SITC) has announced that Paul M. Sondel, MD, PhD, will receive the 2017 Richard V. Smalley, MD Memorial Lectureship Award.