Tuesday, June 27, 2023
GAVRETO was initially approved by the NMPA in March 2021 for the treatment of locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy. Furthermore, in March 2022, it received approval as the first selective RET inhibitor for the treatment of advanced RET-altered thyroid cancer.
The ARROW study demonstrated the efficacy of GAVRETO® (pralsetinib) as a precision therapy for Chinese patients with RET fusion-positive non-small cell lung cancer (NSCLC). It showed strong anti-tumour activity, regardless of prior treatments, and GAVRETO had a manageable safety profile with no new safety signals.
This recent approval of GAVRETO's supplemental new drug application (sNDA) is a crucial milestone in improving clinical outcomes for Chinese patients with RET fusion-positive NSCLC.