Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that v::RET status confers therapeutic sensitivity to Pralsetinib in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized pralsetinib as a monotherapy treatment for adult patients with RET fusion-positive advanced non-small cell lung cancer (NSCLC) who have not previously been treated with a RET inhibitor.
This statement is based on a regulatory approval from the European Medicines Agency:
Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.