Haematology – Page 4 – Medical News Asia

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

14 June 2018/1 Comment/in US FDA Onc\Haem Approvals, Haematology, Oncology, Immunotherapy/by scienterrific

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

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

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

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

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 and BiTE immunotherapy – Updated 2-May-2018

2 May 2018/5 Comments/in Haematology, Oncology, Immunotherapy/by Stijn van den Borne, MSc

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

30 April 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Melanoma & Skin Cancer/by scienterrific

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%

29 March 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Immunotherapy/by scienterrific

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and paediatric patients with B-cell precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. More Information.