FDA grants AstraZeneca's orphan drug for small cell lung cancer

AstraZeneca, thepharmaceutical(http://giant, announced that theAuthority for food anddrugs(http:// (
) of theFDA (http:// had granted the PD-L1 tumor immunotherapy Imfinzi (SCLC) to treat small cell lung cancer (SCLC)In June of this year, the phase III clinical study CASPIAN of Imfinzi's first-line treatment for wide-term small cell lung cancer (ES-SCLC) reached its main endpoint, showing a statistically significant and clinical improvement in the total survival (OS) of the Imfinzi-chemotherapy treatment group compared to the chemotherapy groupAstraZeneca is also conducting another Phase III clinical study, ADRIATIC, to receive Imfinzi treatment after synchronic chemotherapy (CCRT) for SCLC patientsAbout ImfinziImfinzi is a PD-L1 immunotherapy that targets binding to cell-programmed death factor ligand 1 (PD-L1), blocks the interaction between PD-L1 and PD-1 and CD80, fights the tumor's immune escape strategy and releases the inhibitory effect of the immune responseCurrently, Imfinzi has been approved by many countries and regions, including Hong Kong and Macau, for the treatment of patients with advanced bladder cancer who have been treated in the pastFor lung cancer, Imfinzi has been approved by more than 45 countries worldwide (including the United States, the European Union, Japan) for treatment of patients with non-reprecyibility of late local (phase III) NSCLCThe approval is based on data from the PHASE III study of PACIFIC In early June, three-year OS data presented at the annual meeting of the American Society of Clinical Oncology (ASCO) showed that long-lasting and persistent OS benefits were observed in patients with non-rectructive phase III NSCLC who did not progress after simultaneous chemotherapy (CRT): the Three-year OS rate was 57% in the Imfinzi treatment group, the median OS was not reached, and the placebo group had a three-year OS rate of 43.5%, and the median OS was 29.1 months Based on this result, Imfinzi became the first immunotherapy to be shown to have a three-year survival benefit in the non-rectructability Phase III NSCLC group