Industry News & Regulatory Approvals

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.

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.

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.

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

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.

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

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

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.