Business
Imfinzi new dosing approved in EU
Imfinzi new dosing approved in EU.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8327L\n AstraZeneca PLC\n 15 January 2021\n \n \n \n 15 January 2021 07:00 GMT\n \n \n \n Imfinzi\n \n \n approved in the EU for less-frequent, fixed-\ndose use in unresectable non-small cell lung cancer\n \n \n \n \n \n \n New option extends dosing from two to four weeks,\nreducing medical visits and improving patient convenience\n \n \n \n \n AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union and the UK for an additional dosing option, a 1,500mg fixed dose every four weeks, in locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (CRT).\n \n Lung cancer is the leading cause of cancer death and 80-85% of patients with lung cancer have NSCLC.1-3 Approximately one third of patients are diagnosed in the Stage III setting and the majority of these have unresectable tumours and are treated with curative intent.3-5\n \n \n \n This new dosing option is consistent with the approved Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and is available to patients with locally advanced, unresectable NSCLC weighing more than 30kg.\n \n \n \n \n The approval by the European Commission was based on data from several Imfinzi clinical trials. These include the PACIFIC Phase III trial which supported the two-week, weight-based dosing of 10mg/kg already approved in locally advanced, unresectable NSCLC, and the CASPIAN Phase III trial which used four-week, fixed dosing during maintenance treatment in ES-SCLC.\n \n \n \n \n The approval follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which recommended approval in December 2020. This CHMP recommendation and approval also apply to the UK.\n \n \n \n \n Luis Paz-Ares, MD, PhD, Chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator in the CASPIAN Phase III trial, said: \"Less-frequent dosing is important for cancer patients, and may be particularly relevant right now for those suffering from lung cancer, who are especially vulnerable to complications from COVID-19. Patient...