What is new in the treatment of haematologic malignancies? Read our haematology blog and learn more about the latest advancements in the treatment of haematologic malignancies.

Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients

On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).

Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)

On 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

U.S. FDA approved immunecheckpoint inhibitors U.S. FDA approved immunotherapies for cancer U.S. FDA approved immunotherapies for cancer

US FDA approved immune-checkpoint inhibitors updated 11-Dec-2018

Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.

MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab

MURANO: off-drug progression-free survival after 2 years venetoclax plus 6 cycles Rituximab

On the first day of the 2018 American Society of Hematology (ASH) Annual Meeting, an additional year of follow-up data from the practice-changing MURANO study were presented to the audience by Professor John F. Seymour. In the trial’s setting of relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL), the non-chemo-containing regimen venetoclax (Venclexta®, AbbVie/Roche) plus rituximab was associated with maintained superior progression-free survival (PFS) and overall survival (OS) over standard-of-care chemoimmunotherapy with bendamustine plus rituximab. At the same time, a durable post-treatment disease control is also attainable with the fixed-duration chemo-free regimen.

Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations

On 28 November 2018, the FDA approved gilteritinib (Xospata® [ASP2215], Astellas) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML) harbouring FLT3 mutations as confirmed by an FDA-approved companion diagnostic test (CDx).

Venetoclax plus azacitidine, decitabine, or low-dose cytarabine FDA approved in elderly AML patients

On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in patients with comorbidities precluding intensive induction chemotherapy.

Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients

On 21 November 2018, the FDA approved glasdegib (Daurismo®, Pfizer) in combination with low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in patients of 75 years or older and in patients with comorbidities contraindicating intensive induction chemotherapy.

Emapalumab FDA approved in adult and paediatric patients with primary hemophagocytic lymphohistiocytosis

On 20 November 2018, the FDA approved the interferon-γ neutralising monoclonal antibody emapalumab (Gamifant®, Novimmune) for the treatment of adult and paediatric (newborn and older) patients with refractory, recurrent, or progressive primary haemophagocytic lymphohistiocytosis (HLH) or in patients intolerant to conventional HLH therapy.

Brentuximab vedotin (Adcetris®) plus chemotherapy approved for several CD30 expressing lymphomas

On 16 November, 2018, the FDA approved brentuximab vedotin (Adcetris®, Seattle Genetics) in combination with chemotherapy for the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS).

CAR-T axicabtagene ciloleucel granted Orphan Drug Designation for B-Cell Lymphoma by the Japan MHLW

CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW

TOKYO and BASKING RIDGE, N.J., October 3, 2018 /PRNewswire/ — The Japan Ministry of Health, Labour and Welfare (MHLW) granted the Orphan Drug designation to axicabtagene ciloleucel (KTE-C19, Daiichi Sankyo) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL),  high-grade B-cell lymphoma (HGBL), and transformed follicular lymphoma (TFL), which are all aggressive forms of non-Hodgkin lymphoma (NHL).