IndicationsPralsetinib is a kinase inhibitor indicated for the treatment of:
- Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.
- Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.
- Adult and pediatric patients 12 years of age 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).
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.Dosage and Administration
- Select patients for treatment with LuciPral based on the presence of a RET gene fusion or mutation.
- The recommended dose for adults and pediatric patients 12 years of age and older is 400 mg taken orally once daily on an empty stomach (at least 1 hour before or 2 hours after a meal).
Specification
100 mg per capsule, 60 capsules per box.
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