Lung cancer's first HER2-guided therapy! AstraZeneca/First Three-Target Drug Enhertu is awarded the third breakthrough drug by the FDA!

2020 May 19 News /BioValleyBIOON / -AstraZeneca(AstraZeneca) and the first three-partner total pharmaceutical (DaiichiSankyo) have jointly announced that the US food and Drug Administration (
FDA) has granted HER2-targeted antibody drug conjugates (ADC) Enhertu (fam-trastuzumabderuxtecan-nxki, DS-8201 ) Drug qualification breakthrough (the BTD), for the treatment of accepting progression, metastatic HER2-mutated non-small cell lung cancer (NSCLC)presence of a tumor during or after the platinum-containing chemotherapyis worth mentioning that this is available in U.SEnhertu regulatory third BTDLast week, the US FDA granted Enhertu for the treatment of previously received at least two kinds of programs (including trastuzumab, trastuzumab) in HER2-positive, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma patients BTD2017,FDAalso awarded BTD Enhertupatients with HER2-positive metastatic breast cancer, the treatment indication was approved in December 2019NSCLC is the most common type of lung cancer, especially metastatic disease in patients with poor prognosis, only 6-10% of patients surviving five years after diagnosis Presence of tumor HER2 mutations about 2-4% of patients with NSCLC currently in NSCLC treatment, targeted therapy and immunotherapy is showing great progress But do not benefit from such therapy or continued progression of cancer HER2 mutations in NSCLC patients, there are still significant unmet medical needs present, for the HER2mNSCLC patients, no drugs approved If approved, Enhertu HER2 directed therapy has the potential to become the first to be approved for the treatment of NSCLC The FDA a grant EnhertuBTD, based on ongoing assessment Enhertu treating HER2 mutations (HER2m) II trial of DESTINY-Lung01 metastatic NSCLC patient data and published in "Cancer discovery" data on the phase I trial (CancerDiscovery) DESTINY-Lung01 interim analysis of data in 2020, May 29 - posted on the Virtual meeting held 31 American Society of Clinical tumor Annual Meeting (ASCO20) HER2 promote cell growth is a receptor protein tyrosine kinase, expressed in a variety of cell surface gastric cancer, breast cancer, lung cancer Overexpression of HER2 HER2 gene with a particular change (amplification of HER2) related, often associated with aggressive disease and poorer prognosis Other genetic alterations a HER2 (HER2 become mutation) has been found in NSCLC, especially in adenocarcinoma, is considered a distinct molecular targets HER2 mutations presence of about 2-4% of the tumor NSCLC patients, these mutations were independently associated with cancer cell growth and poor prognosis Enhertu (trastuzumabderuxtecan, DS-8201) is a new generation of antibody drug conjugates (ADC), by means of a link sub-4 peptide targeting HER2 humanized monoclonal antibody of trastuzumab (Trastuzumab single antibodies) and a novel derivative topoisomerase 1 inhibitor exatecan (DX-8951 derivatives, DXD) linked together, can be targeted delivery of cytotoxic agents into cancer cells, as compared with conventional chemotherapy may be reduced systemic cytotoxic agent exposure 2019 March AstraZeneca and Daiichi Sankyo entered into tumor immune Cooperation a total value of up to $ 6.9 billion, to develop Enhertu, for the treatment of a variety of HER2 expression level of a cancer patient or a HER2 mutations, including gastric, colorectal cancer and lung cancer, breast cancer and low expression of HER2 Under the agreement, the two sides will jointly develop on a global scale and commercialization Enhertu, Daiichi Sankyo exclusive rights to the Japanese market reserves, while solely responsible for manufacturing and supply Enhertu in December 2019 in the United States the world's first: FDA won accelerated approval for metastatic disease have received more than two or two anti-HER2 therapy HER2-positive metastatic breast cancer in adult patients In Japan, Enhertu obtained in March 2020 the Japanese Ministry of Health, Labor and Welfare (MHLW) early conditional approval for the treatment of HER2-positive, unresectable or metastatic, recurrent after prior chemotherapy in breast cancer patients (restricted to standard treatment of patients with ineffective or not tolerated) pharmaceutical market research firm EvaluatePharma had predicted, Enhertu sales in 2024 are expected to reach $ 2 billion (Biovalley Bioon.com) ORIGINAL: EnhertugrantedBreakthroughTherapyDesignationintheUSforHER2-mutantmetastaticnon-smallcelllungcancer