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Enhertu US Breakthrough status for lung cancer
Enhertu US Breakthrough status for lung cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 1709N\n AstraZeneca PLC\n 18 May 2020\n \n \n \n 18 May 2020 07:00 BST\n \n \n \n Enhertu \n \n \n granted \n \n \n Breakthrough Therapy Designation in the US \n \n \n for\n \n \n HER2-mutant metastatic non-small cell lung cancer\n \n \n \n \n Third Breakthrough Therapy Designation for Enhertu\n \n \n \n AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.\n \n \n \n \n \n NSCLC is the most common type of lung cancer, and prognosis is particularly poor for patients with metastatic disease as only about 6-10% will be alive five years after diagnosis.1,2 Approximately 2-4% of patients with NSCLC have a HER2 mutation.3,4 \n \n \n \n \n \n The Food and Drug Administration (FDA)'s BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.\n \n \n \n \n José Baselga, Executive Vice President, R&D Oncology, said: \"Today's news is very welcome as we continue to evaluate the potential of Enhertu to help patients with this devastating type of lung cancer. Targeted treatments and immunotherapies are demonstrating tremendous advancements, but there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress.\"\n \n \n \n Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: \"We are encouraged by the promising evidence of activity seen with Enhertu in patients with advanced lung cancer and a HER2 mutation. We look forward to working closely with the FDA on the potential for Enhertu to become the first HER2-directed therapy approved for non-small cell lung cancer.\"\n \n \n The FDA granted BTD based on data from the on...