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

In other recent regulatory news, Health Canada authorized amivantamab in combination with carboplatin and pemetrexed for patients with non-small cell lung cancer with EGFR Exon 20 insertion mutations. Read more

The European Commission has approved adjuvant alectinib for ALK+ early-stage NSCLC while the US FDA has granted priority review for osimertinib for unresectable stage III EGFR+ NSCLC. Read more

The first-in-class immunotherapy offers a new option for SCLC patients with disease progression on or after platinum-based chemotherapy. Read more

In other regulatory news, the US FDA recently granted a Breakthrough Therapy Designation for sunvozertinib for first-line treatment of advanced non-small cell lung cancer with EGFR Exon 20 Insertion mutations. Read more

The US approved alectinib as adjuvant treatment based on a significant DFS benefit compared to chemotherapy. Read more

US FDA grants accelerated approval of HER2-targeting antibody drug conjugate; China accepts supplemental new drug application for savolitinib. Read more