Leukemia heavy news! Amjin Bite immunotherapy Blincyto has been approved by the European Union to eradicate micro-residual lesions (MR.

the US biotech giant Amgen's BiTE immunotherapy blinatumomab has been in good news for EU regulation. The European Commission (EC) has approved the expansion of the adaptation of Blincyto single-drug therapy for the first or second complete remission of post-ADHD ≥0.1% of Philadelphia chromosomal-negative, CD19-positive pre-body B-cell acute lymphoblastic leukemia (pre-B ALL) adult patients.approval also makes Blincyto the first and only drug approved for MRD in the European Union. In the United States, Blincyto was approved by the FDA at the end of March 2018 for the treatment of MRD≥0.1% of pre-B ALL adult and child patients after first or second full remission. In ALL patients, the detection of residual cancer cells (i.e. MRD) after complete remission is the strongest prognostic factor for assessing recurrence.Blincyto is the world's first and only CD19-CD3 dual-specific T-cell convergence (BiTE) immunotherapy, the first dual-specific antibody product born by Amgen's Bite technology platform, which activates the immune system to identify and kill tumor cells by presenting CD19 proteins on tumor cells to CD3 proteins specifically expressed by T-cells.this approval is based on MRD remission rate and hematological recurrence rate (RFS) data based on single-arm Phase II clinical study BLAST (n-86). The study is the largest prospective study ever conducted in the MRD-positive ALL patient population. Data show that after a cycle of treatment with Blincyto, 78% of MRD-positive patients switched to MRD-negative, reaching the main endpoint of the study (95% CI:71.6-89.0), with a mesothermatological RFS of 22.3 months. In terms of safety, the safety results observed in MRD-positive patients are consistent with the known safety of Blincyto's recurring or resecurable pre-B ALL. The most common adverse reactions (>20%) were fever, injection site reactions, headaches, infections (pathogens unknown), tremors and chills.micro-residual disease (MRD) refers to a small amount of cancer cells remaining in the body, although the patient has been routinely assessed after treatment and although it has reached complete remission. MRD cannot be detected through routine imaging and laboratory tests, and cancer cells present in the bone marrow can only be detected by highly sensitive tests. For example, conventional microscopes assess a sensitivity of only one in twenty, i.e. one cancer cell out of 20 cells, while a highly sensitive test can detect one cancer cell in 10,000 cells."Continued confirmation of MRD status as an approved endpoint is an important step in the transformation of the ALL clinical management model, as early intervention throughout ALL treatment has proven to be an important step in eliminating dangerous detectable diseases," said Dr. David M. Reese, Senior Vice President of Translational Sciences and Oncology atAmjin. This approval will enable Blincyto to be used at an earlier stage throughout ALL treatment, destroying traces of detectable leukemia and enabling patients to have a better prognostication.BiTE immunotherapy mechanismsBiTE antibody technology represents an innovative immunotherapy that works at very low concentrations. AmSe acquired Bite technology in 2012 after buying Micromot for $1.2 billion. Currently, Amjin is exploring the potential of BitE's innovative therapies in a wide range of incurable tumor types. Previously, both fda and EMA have awarded blinatumomab orphan status and breakthrough therapy for a variety of types of blood cancers, including acute lymphoblastic leukemia (ALL), chronic lymphoblastic leukemia (CLL), hair cell leukemia (HCL), young lymphocytic leukemia (PLL) and inert B-cell lymphoma, clergy leukemia (MCL). (Bio Valley)