Indications of Pralsetinib

The indications stated in this package insert are based on the mechanism of action of pralsetinib as a selective RET inhibitor, and apply to patients who meet the following criteria:

1. Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Pralsetinib is indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by a test approved by the U.S. Food and Drug Administration (FDA).

2. RET Fusion-Positive Thyroid Cancer

Pralsetinib is indicated for the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine refractory (if radioactive iodine is appropriate for use).

This indication is approved under the accelerated approval pathway based on the overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon the verification and clarification of clinical benefit in confirmatory clinical trials.

from FDA，2024.03