Her2 plus breast cancer heavy new drug! AstraZeneca/I-Sanantibodies-Drug Conjugate Enhertu EU Entry Review, Total Mitigation Rate 60.3%

, July 07, 2020 //BiovalleyBIOON/--Daiichi Sankyo has announced that the European Medicines Agency (EMA) has accepted theof the new drug Enhertu (fam-trastuzumab deruxte), a new drug for breast cancerCan, DS-8201) Marketing Authorization Application (MAA), a target ingenuated with HER2 antibody drug conjugate (ADC), is used to treat patients with non-removable or metastatic HER2-positive breast cancer who have previously received at least 2 anti-HER2 treatment regimensThe EMA Human Medical Products Committee (CHMP) has awarded Enhertu an accelerated assessment and has initiated a scientific reviewCHMP typically evaluates products that are expected to be significant for public health and treatment innovation, which will significantly reduce the review timeEnhertu is developed globally in partnership withAstra
Zeneca, with the first three retaining exclusive rights to the Japanese marketIn the United States and Japan, Enhertu has been approved for use in adult patients who have previously received at least 2 HER2 programs for non-removable or metastatic HER2-positive breast cancerThe drug approval is based on data ontumormitigation rate (ORR - 60.3%) and duration of reliever (median DOR -14.8 months) based on the registration phase II trial DESTINY-Breast01Further approval will depend on the validation and description of clinical benefits in validation trialsIt is important to note that Enhertu's drug label contains a black box warning that indicates interstitial pulmonary disease (ILD)/pneumonia and fetal toxicityDr Gilles Gallant, Global Head of Oncology
research and development at the , said: "The accelerated assessment in the EU highlights the significant lying unmet medical needs in patients with HER2-positive metastatic breast cancer, which Enhertu has the potential to address The drug is already in use in patients in the United States and Japan, and we look forward to working with EMA to bring this important new drug to patients in the European Union as soon as possible "
DESTINY-Breast01 is a critical, one-arm, open-label, global, multi-center, two-part trial that evaluated the safety and efficacy of Enhertu (5.4mg/kg) as a monodrug treatment for PATIENTs with HER2-positive, non-removable and/or metastatic breast cancer The study involved 184 patients in more than 100 clinical sites worldwide who had previously received two or more HER2 targeted protocols, with a median treatment of metastatic diseases of 6 (range: 2-27), including: trastuzumab-emtansine (Tstuzumab-emtansine) -DM1, 100% of patients), quralmon (100% of patients), pertuzumab (65.8% of patients), other anti-HER2 therapy (54.3% patients), hormone therapy (48.9% patients) and other systemic therapy (99.5%) patients) The main endpoint of the study was the Total Mitigation Rate (ORR), which was evaluated by the Independent Central Review Board (IRC) In the study, Enhertu's median treatment time was 10 months (0.7-20.5) and the median follow-up time was 11.1 months (0.7-19.9) As of August 1, 2019, 42.9% of patients were still receiving treatment the results of the study have been published in the New England Journal of Medicine (NEJM) The data showed that the ORR for Enhertu single drug (5.4mg/kg) was 60.3% (n-111,95% CI:52.9-67.4), of which the total mitigation rate (CR) was 4.3% (n-8) and the partial mitigation rate (PR) was 56.0% The disease control rate (DCR) was 97.3%, the median duration of remission (DoR) was 14.8 months (95% CI: 13.8-16.9), and the median progression-free survival (PFS) was 16.4 months (95% CI: 12.7-unpredictable) The median total lifetime (OS) has not yet been achieved, with an estimated one-year survival rate of 86 per cent The results were consistent among the subgroups The safety and tolerance of DS-8201 in this study was consistent with that observed in Phase I trials about 20% of breast cancer cases are HER2 positive, and although treatment has progressed in recent years and several new drugs have been approved, there is still a significant clinical need in PATIENTs with HER2-positive metastatic breast cancer The disease is still incurable and patients will eventually progress after receiving the treatment currently available HER2 is a tyrosine kinase receptor growth protein that is expressed on the surface of a variety of tumors cells, including stomach, breast and lung cancer, and is associated with invasive diseases and poor prognosis Enhertu is a new generation of ADC drugs that link human-derived monoclonal antibody trastuzumab (qurstagun monotagism) targeting HER2 with a new type of topological isosome1 inhibitor exatecan derivative (DX-8951 derivative, DXd) that can target cell delivery into cancer cells and reduce systemic exposure to the usual chemotherapy March 2019, AstraZeneca and I3 agreed to a $6.9 billion immuno
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Oncology to develop Enhertu to treat cancer patients with various HER2 expression levels or HER2 mutations, including stomach, colorectal and low-expression breast cancer Evaluate Pharma, a pharmaceutical market research firm, had forecast that Enhertu's sales would reach $2 billion in 2024 (BioValleyBioon.com) original source: EMA Validates and Grants Steped Assessment for Trastuzumab Deruxtecan for The Treatment of Her2 Positive MetastaticBreast Cancer