HEMATOLOGY

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.

According to results from a trial conducted by investigators from the Children&rsquo;s Oncology Group, treatment with arsenic trioxide consolidation was effective and safe in newly diagnosed pediatric patients with acute promyelocytic leukemia, allowing a significant reduction in cumulative anthracycline doses.

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.

Carfilzomib (Kyprolis) reduced the risk of death by 21% compared with bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, according to results from the phase III ENDEAVOR trial, now published in the<em> Lancet Oncology.</em>

Sattva S. Neelapu, MD, associate professor, The University of Texas MD Anderson Cancer Center, discusses the design of the ZUMA-1 trial in non-Hodgkin lymphoma.

Inotuzumab ozogamicin (Besponsa) has received FDA approval for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), based on findings from the phase III INO-VATE trial.

A supplemental biologics license application (sBLA) for brentuximab vedotin (Adcetris) has been granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma (CTCL), according to Seattle Genetics, which codevelops the antibody-drug conjugate with Takeda.

Suzanne L. Topalian, MD, director, Melanoma Program, professor of Surgery, Johns Hopkins Medicine, discusses the impact of anti-PD-1 and anti-PD-L1 agents in the treatment of merkel cell carcinoma.

Development of chimeric antigen receptor T-cell therapies is in the works for both hematologic malignancies and solid tumors, but the most promising results to date have been seen with CD19-targeted CAR T cells in the treatment of B-cell acute lymphoblastic leukemia.

Sagar Lonial, MD, professor and chair, Department of Hematology &amp; Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses the importance of partnering with a myeloma center when managing multiple myeloma.

Shaji Kumar, MD,&nbsp;discusses ixazomib, daratumumab triplets, denosumab, and CAR T-cell therapy in multiple myeloma.

Supplemental New Drug Applications were recently submitted in the United States and Europe for carfilzomib (Kyprolis). The sNDAs were submitted based on data from 2 phase III studies showing carfilzomib improves overall survival for patients with relapsed/refractory multiple myeloma. &nbsp;

The combination of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone reduced the risk of death by 21% compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma following prior treatment with 1 to 3 regimens.

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.

Duvelisib, a PI3K-delta/gamma inhibitor, in combination with fludarabine, cyclophosphamide, and rituximab showed high rates of responses and bone marrow minimal residual disease negativity in younger patients with previously untreated chronic lymphocytic leukemia.

Keith Stewart, MB, ChB, discusses treatment decisions centered around the care of patients with multiple myeloma, including the roles of autologous stem cell transplant and MRD testing.

Sagar Lonial, MD, professor and chair, Department of Hematology &amp; Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University, discusses CAR T-cell therapy for myeloma and other hematologic malignancies.

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.

A new drug application (NDA) for acalabrutinib has been granted a priority review by the FDA for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor.

A look back at all the FDA news that occurred in July.

Acalabrutinib has been granted a breakthrough therapy designation by the FDA for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor.

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.

Obinutuzumab (Gazyvaro, EU; Gazyva, US) has been recommended for approval by the European Medicines Agency&rsquo;s&nbsp;Committee for Medicinal Products for Human Use (CHMP) in the frontline setting for the treatment of patients with follicular lymphoma.

Sundar Jagannath, MDDS, professor, Medicine, Hematology, and Medical Oncology, Mount Sinai Hospital, discusses the mechanism of action of selinexor for the treatment of multiple myeloma.

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.

A supplemental new drug application for dasatinib (Sprycel) for use in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia has been accepted by the FDA.

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.