Hematology

The FDA has granted a breakthrough therapy designation to zanubrutinib (BGB-3111) for use in some patients with mantle cell lymphoma.

Axicabtagene ciloleucel (axi-cel) elicited a 2-year overall survival (OS) rate of 51% in patients with refractory large B cell lymphoma, representing a clear plateau in the survival curve.

The median overall survival for patients with chronic lymphocytic leukemia has more than tripled since the 1970s, primarily due to an ever-expanding armamentarium of novel agents and earlier diagnosis.

The anti-BCMA CAR T-cell therapy bb21217 demonstrated an objective response rate of 83.3%, with a very good partial response or better rate of 75% in patients with heavily pretreated relapsed/refractory multiple myeloma, according to initial results from a phase I study presented at the 2018 ASH Annual Meeting.

The FDA has approved ravulizumab-cwvz (Ultomiris) as an injection treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder that leads to hemolysis.

In patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), high doses of curcumin and vitamin D could help stabilize the disease, according to new research presented at the 2018 American Society of Hematology’s Annual Meeting in San Diego.

The FDA approved tagraxofusp-erzs (Elzonris) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 or older.

The Food and Drug Administration approved calaspargase pegol-mknl (Asparlas) as a component of a chemotherapy regimen to treat adult and pediatric patients with acute lymphoblastic leukemia, according to the agency.

Treatment with luspatercept significantly reduced the need for frequent red blood cell transfusions in nearly 53% of patients with anemia associated with low- to intermediate-risk myelodysplastic syndrome (MDS), according to results from the phase III Medalist trial presented at the 2018 ASH Annual Meeting.

Lisocabtagene maraleucel (liso-cel; JCAR017) appeared tolerable and induced an 81.3% best overall response rate and 43.8% complete response rate in heavily pretreated, high-risk patients with chronic lymphocytic leukemia (CLL) who previously received ibrutinib (Imbruvica), according to dose-finding results of a small phase I/II trial.

Hematologists may have the ability to determine acute myeloid leukemia (AML) subtype based on genetic analysis of blood samples in 7 days or less, a process that could soon be an integral part of diagnosing and treating this patient population, according to Amy Burd, PhD.

Receiving a stem cell transplant for the first time following CD19 CAR T-cell therapy induced a reduction in the risk for acute lymphoblastic leukemia (ALL) recurrence, according to a retrospective analysis of the phase I/II PLAT-02 study.1

The triplet of daratumumab (Darzalex), lenalidomide (Revlimid), and dexamethasone (DRd) reduced the risk of disease progression or death by 44% compared with lenalidomide plus dexamethasone (Rd) in newly diagnosed patients with multiple myeloma who were not candidates for high-dose chemotherapy and autologous stem-cell transplant.

The FDA has approved gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).

The FDA has approved the first rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy.

The Food and Drug Administration (FDA) granted a priority review to the FLT3 inhibitor quizartinib for the treatment of relapsed or refractory FLT3-ITD acute myeloid leukemia (AML).

The Food and Drug Administration (FDA) has approved the hedgehog pathway inhibitor glasdegib (Daurismo) for use in combination with low-dose cytarabine (LDAC) for the treatment of acute myeloid leukemia (AML) in newly-diagnosed patients who are aged 75 years or older or who are ineligible for intensive chemotherapy.

The Food and Drug Administration (FDA) has granted an accelerated approval to venetoclax (Venclexta) for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed adult patients with acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The Food and Drug Administration (FDA) expanded the approval of eltrombopag (Promacta) in combination with standard immunosuppressive therapy to include first-line use in newly diagnosed adult and pediatric patients aged 2 years and older with severe aplastic anemia.

The Food and Drug Administration (FDA) has approved the use of brentuximab vedotin (Adcetris) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

The Food and Drug Administration (FDA) has granted a breakthrough therapy designation to brentuximab vedotin (Adcetris) for use in combination with chemotherapy for the first-line treatment of CD30-expressing peripheral T-cell lymphoma (PTCL).

Elise James, LCSW, and Mayra Garcia, LCSW, describe the Stem Cell Transplant Meet and Greet program at The Sylvester Comprehensive Cancer Center, which provides psychosocial support to pre-transplant patients.

The Aplastic Anemia & MDS International Foundation (AAMDSIF), the world's leading non-profit health organization dedicated to serving patients afflicted with bone marrow failure disease, announced today that Neil Horikoshi has been named the Foundation's new Chief Executive Officer and Executive Director.

Selinexor has been granted a fast track designation by the Food and Drug Administration (FDA) to treat previously treated patients with diffuse large B-cell lymphoma (DLBCL) who are ineligible to receive high-dose chemotherapy with stem cell rescue or chimeric antigen receptor (CAR) T-cell therapy.

The FDA has approved elotuzumab (Empliciti) for use in combination with pomalidomide (Pomalyst) and low-dose dexamethasone (EPd) for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.

Treatment for multiple myeloma is quickly evolving. To bring physicians, nurses, and other members of the community oncology care team up to date, Abhinav B. Chandra, MD, MSc, FACP, conducted a presentation at the Association of Community Cancer Centers (ACCC) 35th National Oncology Conference in Phoenix, Arizona.

Investigators are hopeful that idasanutlin, a novel small molecule that targets the MDM2 protein, is being tested in combination with cytarabine in the international phase III MIRROS clinical trial (NCT02545283) to see if omprove the efficacy of chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML).

The value of axicabtagene ciloleucel (axi-cel; Yescarta), an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in treating R/R MCL will be tested in the multi­center phase II ZUMA-2 clinical trial (NCT02601313).

The FDA has granted a priority designation to a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) for use in combination with obinutuzumab (Gazyva) for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of CT-P10, a biosimilar for the monoclonal antibody rituximab (Rituxin), for 3 non-Hodgkin lymphoma indications in a 16-0 vote.