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Media Thread, page-14635

  1. 28 Posts.
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    I agree, you only have to look at Blincyto history of approval as another example. I have to say, AMGEN did a great job in getting this drug approved so quickly.

    Development timeline for Blincyto

    The drug (originally known as MT103) was developed by a German-American company Micromet, Inc. in cooperation with Lonza; In 2012, Micromet was purchased by Amgen, which furthered the drug's clinical trials.
    DateArticle
    1Jun 14, 2024ApprovalFDA Approves Blincyto (blinatumomab) in CD19-Positive Philadelphia Chromosome-Negative B-ALL in the Consolidation Phase
    2Jun 21, 2023ApprovalFDA Grants Full Approval for Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
    3Mar 29, 2018ApprovalFDA Expands Approval of Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
    4Jul 11, 2017ApprovalFDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children
    5Sep 1, 2016ApprovalFDA Approves Blincyto (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia
    6Dec 3, 2014ApprovalFDA Approves Blincyto (blinatumomab) for Precursor B-Cell Acute Lymphoblastic Leukemia
    7Oct 9, 2014Amgen's BiTE® Immunotherapy Blinatumomab Receives FDA Priority Review Designation In Acute Lymphoblastic Leukemia
    8Sep 22, 2014Amgen Submits BLA for Investigational BiTE® Immunotherapy Blinatumomab
    9Jul 1, 2014Amgen Receives FDA Breakthrough Therapy Designation For Investigational BiTE Antibody Blinatumomab In Acute Lymphoblastic Leukemia
    Source: https://www.drugs.com/history/blincyto.html and https://en.wikipedia.org/wiki/Blinatumomab

    Cost
    When blinatumomab was approved, Amgen announced that the price for the drug would be US$178,000 per year, which made it the most expensive cancer drug on the market. Merck's pembrolizumab was priced at US$150,000 per year when it launched (in September 2014).[15] At the time of initial approval, only about 1,000 patients in the US had an indication for blinatumomab.




 
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