US FDA grants accelerated approval of HER2-targeting antibody drug conjugate; China accepts supplemental new drug application for savolitinib. Read more
The filing was based on results from a global phase III study designed to compare the ALK inhibitor to crizotinib in the first-line treatment of ALK-positive NSCLC. Read more
The US FDA’s Dr. Harpreet Singh talks with ILCN about what the increasing use of AI means for the agency as it works to ensure drugs and devices are safe and effective. Read more
The move was supported by preliminary evidence from a phase I, first-in-human study in patients with advanced NSCLC. Read more
The agency also granted approval to amivantamab as a treatment for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who progressed on or after platinum-based chemotherapy. Read more
Other recent regulatory moves include the FDA granting full approval to tepotinib for metastatic NSCLC harboring MET exon skipping alterations and new applications for amivantamab in the US and Europe. Read more
The European Commission recently approved adagrasib for KRAS G12C+ non-small cell lung cancer. Additionally, the US FDA has accepted a premarket approval application for tumor treating fields therapy. Read more
October saw two approvals from the US FDA as well as caution from the agency’s Oncologic Drug Advisory Committee regarding the interpretation of CodeBreak 200 data; Takeda announces withdrawal of mobocertinib. Read more
Canada to require health warnings on cigarettes. US FDA approves application for pemetrexed injection, grants priority review for repotrectinib. Read more
Health Canada gives greenlight to cemiplimab-chemo combo for first-line treatment of advanced NSCLC. Early registration for WCLC 23 ends June 9. Read more