Haematology – Page 3 – Medical News Asia

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

5 October 2018/0 Comments/in Medical News Asia, Haematology, Oncology, Immunotherapy/by scienterrific

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).

Duvelisib FDA approved for adult patients with R/R CLL or SLL

25 September 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Targeted Therapies/by scienterrific

On September 24, 2018, the US FDA granted regular approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior therapies.

Duvelisib FDA approved for adult patients with R/R follicular lymphoma

25 September 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Targeted Therapies/by scienterrific

On September 24, 2018, the US FDA granted accelerated approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies.

Moxetumomab pasudotox-tdfk FDA approved for hairy cell leukaemia

14 September 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Targeted Therapies/by scienterrific

On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti®, AstraZeneca) for adult patients with relapsed or refractory (R/R) hairy cell leukaemia (HCL) who had received at minimum two prior systemic therapies, of which one a purine nucleoside analogue (PNA).

Venetoclax FDA label updated to include Minimal Residual Disease negativity data

12 September 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Targeted Therapies/by scienterrific

On the 11th of September 2018, the FDA updated the label of venetoclax tablets (VENCLEXTA®, Abbvie) in combination with rituximab (MabThera®, Roche) to include information about pre-treated patients with chronic lymphocytic leukemia (CLL) in the Phase III MURANO trial who had achieved Minimal Residual Disease (MRD)-negativity.

Quizartinib receives Orphan Drug designation for FLT3-mutated AML in Japan

12 September 2018/0 Comments/in Medical News Asia, Haematology, Oncology, Targeted Therapies/by scienterrific

TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018 — The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.

FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL

9 August 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Chemotherapy/by scienterrific

On the 8th of August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin), a CC chemokine receptor type 4 (CCR4) directed monoclonal antibody, for use in adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).

Lusutrombopag FDA approved for thrombocytopenia in adult chronic liver disease patients

1 August 2018/0 Comments/in Therapeutic Areas, Haematology/by scienterrific

On the 31st of July 2018, the FDA approved lusutrombopag (Mulpleta®, Shionogi) for thrombocytopenia in adult chronic liver disease (CLD) patients scheduled for an invasive medical or dental procedure.

Ivosidenib FDA approved for relapsed or refractory acute myeloid leukemia

23 July 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Targeted Therapies/by scienterrific

On July 20, 2018, the US FDA approved ivosidenib (Tibsovo©, Agios Pharmaceuticals) for use in adult patients with relapsed or refractory acute myeloid leukaemia (AML) harbouring a susceptible IDH1 mutation as detected by an FDA-approved companion diagnostic (CDx) test, the Abbott RealTime IDH1 Assay.

Filgrastim-aafi FDA approved as Filgrastim Biosimilar

20 July 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, AE Management/by scienterrific

On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.