About Pralsetinib

Pralsetinib is a tyrosine kinase inhibitor. It is taken by mouth.

Pralsetinib is a medication approved for RET mutation-positive medullary thyroid cancer (MTC)  and RET fusion-positive differentiated thyroid cancer (DTC) refractory to radioactive iodine (RAI) therapy.

Pralsetinib is indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) .

Non-Small Cell Lung Cancer

Indicated for metastatic rearranged during transfection (RET) gene-positive non-small cell lung cancer (NSCLC)

400 mg PO qDay on an empty stomach

Continue until disease progression or until unacceptable toxicity

Medullary Thyroid Cancer

Indication was withdrawn in the U.S. by manufacturer on July 10, 2023

The decision was made to remove the indication after the confirmatory trial could not fulfill the postmarketing requirement

Thyroid Cancer

Indicated for advanced or metastatic RET-fusion positive thyroid cancer in adults who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate)

400 mg PO qDay

Continue until disease progression or until unacceptable toxicity

Dosage modifications for adverse reactions

First dose reduction: 300 mg PO qDay

Second dose reduction: 200 mg PO qDay

Third dose reduction: 100 mg PO qDay

Unable to tolerate 100 mg qDay: Permanently discontinue