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EC Approves Amgen’s Blincyto for Pediatric Patients

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Amgen’s Blincyto

On August 29, Amgen (AMGN) announced that the EC (European Commission) approved Blincyto as a monotherapy for pediatric patients with Philadelphia chromosome-negative CD19 positive refractory. This drug was also approved for the treatment of relapsed B-Cell precursor acute lymphoblastic leukemia. This approval was based on Study 205. In this article, we’ll look at the drug and study, as summarized in the chart below.

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About Blincyto

Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T cell engager (or BiTE) immunotherapy. It’s the first and only BiTE-approved immunotherapy, and it’s also the first immunotherapy based on the BiTE platform.

In 2015, Blincyto was approved for the treatment of adult patients with Philadelphia chromosome-negative (or Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (or ALL).

About Study ’205

Study ’205 is a Phase 1/2 study that evaluated the efficacy and safety of Blincyto in pediatric patients aged one and older with Ph- refractory or relapsed B-cell precursor acute lymphoblastic leukemia. The total number of patients in the study was 93.

The drug was administered through continuous intravenous infusion. The dosage for Blincyto included five µg/m2 per day for days one to seven, followed by 15 µg/m2 per day for days eight to 28 during the first cycle. This was followed by two weeks off. The dosage was increased to 15 µg/m2 per day for days one to 28, followed by two weeks off in each subsequent cycle.

The First Trust Value Line Dividend ETF (FVD) holds 0.5% of its portfolio in Amgen (AMGN), 0.5% in Bristol-Myers Squibb (BMY), 0.5% in Merck & Co. (MRK), and 0.5% in Pfizer (PFE).

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