CHMP recommends approval to expand anindications for amp; Aprincyto single-drug treatment

recently, the EuropeanMedicines(http://Administration (EMA) humanMedicines(http://Product(http://Committee (CHMP) has issued a positive opinion recommending approval to extend the ansopathic indications of the allergy treatment of Ampinblanca monotherapy for the first or second complete remission of microresidual disease (MRD) of 0.1% of the Philadelphia chromosome negative, CD19 positive precursor B cell acute leukemia (B)Regarding Blincytoin u.Sregulation, Blincyto was approved by theFDA(http://at the end of March for treatment of patients with pre-B ALL adults and children with mrD of 0.1% after first or second full remissionapproval, making Blincyto the first and only FDA-approveddrug(http://to treat MRDIn 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 alleviatedBlincyto is the world's first and only cd19-CD3 bi-specific T-cell convergence (BiTE) immunotherapy, the first bispecific antibody product born on the Amgen BiTE technology platform, to activate the immune system to identify and kill tumor cells by presenting CD19 proteins on tumor cells to CD3 proteins that are specifically expressed by T cellsThe studies
FDA approval and CHMP's recommended approval, are based on MRD remission rate and hematological recurrence-free 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 monthssafetythe safety results observed in PATIENTs with MRD-positive patients are consistent with the known safety of Blincyto treatment for recurrent or refractory pre-B ALLThe most common adverse reactions ( 20%) were fever, injection site reaction, headache, infection (pathogen unknown), tremor, and chills