Though the study is small, the sponsor says results are promising for the first-in-class telomere-targeting agent. Read more
Data from the Beamion LUNG-1 trial show a 71% objective response rate in previously treated patients. Read more
Durvalumab is recommended for approval in the EU, Health Canada approves pembrolizumab, and the US FDA grants priority review to datopotamab deruxtecan. Read more
Dr. Susan Scott discusses how findings from the MARIPOSA and FLAURA-2 trials will be incorporated into clinical practice. Read more
The US FDA grants fast track designation to treat KRAS G12C-mutant metastatic NSCLC and China’s NMPA approves taletrectinib for advanced ROS1-positive NSCLC. Read more
FDA issues draft guidance on the use of AI for biological and drug product submissions, China’s NMPA grants priority review for the combination of savolitinib and osimertinib, and nivolumab and hyaluronidase-nvhy receive FDA approval for subcutaneous injection. Read more
The US FDA approves ensartinib for ALK-positive NSCLC and provides an updated regulatory review of subcutaneous amivantamab. Read more
European Medicines Agency recommends repotrectinib for ROS1-positive NSCLC; FDA approves therapies for NSCLC, LS-SCLC as well as a new diagnostic tool for identifying MET exon 14 skipping alterations. Read more
US FDA greenlights subcutaneous atezolizumab, grants Breakthrough Therapy Designation for novel antibody drug conjugate to treat SCLC. Read more
Fulzerasib becomes the first KRAS G12C inhibitor approved in China. Encorafenib receives approval from the European Commission. The US FDA grants priority review and breakthrough therapy designation to durvalumab for SCLC. Read more