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

U.S. FDA approved immune-checkpoint inhibitors updated 08-Oct-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.

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). 

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

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

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

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

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

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

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 lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. More Information.  July 31, 2018.

FDA approved mogamulizumab for adult patients with relapsed or refractory CTCL

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).

FDA approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. More Information.  July 31, 2018.

Lusutrombopag FDA approved for thrombocytopenia in adult chronic liver disease patients

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

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.

FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information.  July 13, 2018

Filgrastim-aafi FDA approved as Filgrastim Biosimilar

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.

FDA approved pembrolizumab for 3rd-line PMBCL in adult and pediatric patients

 

  • On June 13, 2018, the US FDA has granted accelerated approval to pembrolizumab (KeytrudaⓇ, Merck & Co. Inc.) for the treatment of adult and pediatric patients with primary mediastinal large B-cell lymphoma (PMBCL), relapsed after two or more prior lines of prior therapy.

FDA approves venetoclax in 2nd-line for patients with CLL or SLL

 

  • FDA granted regular approval to venetoclax (VENCLEXTA,  AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy

 

  • FDA approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH), a biosimilar of Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection due to febrile neutropenia in patients receiving myelosuppressive chemotherapy with clinically significant incidence of febrile neutropenia and with non-myeloid cancers.
US FDA approved CAR-t cell BiTE DAR-T cell CD19 Immunotherapies blinatumomab axicabtagene ciloleucel tisagenlecleucel

US FDA approved CAR-T cell and BiTE immunotherapy - Updated 2-May-2018

The two CAR-T cell immunotherapies axicabtagene ciloleucel (Yescarta®) and tisagenlecleucel (Kymriah®) and the BiTE blinatumomab (Blincyto®) have in common that they target CD19 on the cancer cells. Do you know all the US FDA approved CAR-T and BiTE immunotherapies?

Adjuvant dabrafenib plus trametinib FDA approved for BRAF V600E or V600K melanoma

The FDA granted regular approval to dabrafenib (Tafinlar®, Novartis) and trametinib (Mekinist®, Novartis) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. 

FDA granted accelerated approval to blinatumomab for the treatment of adult and paediatric patients with B-cell precursor ALL in first or second complete remission with MRD ≥0.1%

 

PD-L1 Biomarker for Response DAKO 22C3 - MediPaper Medical Communications

PD-L1 Biomarker: a Comparison of ASCO2016 PD-1 and PD-L1 Data

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ESMO 2016 nivolumab data medipaper medical communications

ESMO16 Nivolumab data - Download the PPT

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