European Commission approves expansion of allergy to blinatumomab monodruga treatment

recently, the US biotech giant Amgen BiTE immunotherapy blinatumomab on EU regulation spoutEuropean Commission (EC) has approved the expansion of Blincyto monotherapy for the treatment of adult patients with Blincyto monodrugation therapy for adult patients with first or second complete remission of microresidual disease (MRD) of 0.1% Of Philadelphia chromosome-negative, CD19-positive precursor B-cell acute lymphocytic leukemia (pre-B ALL)in the United States, Blincyto was approved by theFDA(http://at the end of March 2018 for the treatment of patients with pre-B ALL adults and children with mr0.1% after first or second full remissionIn ALL patients, thedetected(http://residual cancer cells (i.eMRD) were the strongest prognostic factors for assessing the recurrence of the disease after the condition was fully alleviatedthe approval of theof the study is based on MRD remission rate and hematological non-recurrence survival (RFS) data for the single arm PHASE II clinical study BLAST (n-86)The study is the largest prospective study to date in the PATIENT population of MRD-positive ALLdata show that 78% of PATIENTS WITH MRD-positive patients who received a cycle of Blincyto were positive for MRD, reaching the main end of the study (95% CI: 71.6-89.0) and a median hematological RFS of 22.3 monthssafety the safety results observed in PATIENTs with MRD-positive patients are consistent with the known safety of Blincyto treatment for recurrent or refractory pre-B ALL The most common adverse reactions ( 20%) were fever, injection site reaction, headache, infection (pathogen unknown), tremor, and chills