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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-Nov-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.

Iobenguane I-131 FDA approved for rare adrenal neuroendocrine tumours

On July 30, 2018, the FDA approved iobenguane I-131 (Azedra®, Progenics Pharmaceuticals), a radioactive therapeutic agent, for the treatment of adult and paediatric patients ≥12 years with iobenguane scan positive, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) not amenable to surgery and indicated for systemic therapy.

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.
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?

Everolimus suspension approved in TSC-associated partial-onset seizures

On April 10, the FDA approved everolimus tablets for oral suspension (Afinitor Disperz®, Novartis) for the adjunctive treatment of adult and pediatric patients ≥2 years with tuberous sclerosis complex (TSC)-associated partial-onset seizures.

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%

 

FDA approved nilotinib for paediatric patients with newly diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior TKI

 

Hydroxyurea FDA approved for the reduction in frequency of painful crises and blood transfusions in paediatric sickle cell anemia patients

On 21 December the FDA granted regular approval to hydroxyurea (Siklos®, Addmedica) for the reduction in frequency of painful crises and the need for blood transfusions in paediatric sickle cell anaemia patients ≥2 years of age with recurrent moderate to severe painful crises.