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
The UK recently moved to ban smoking for individuals born after 2009 while the US delayed implementation of a ban on menthol cigarettes—again. Read more
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