Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that v::ALK status confers therapeutic sensitivity to Lorlatinib in patients with Non-Small Cell Lung Cancer.
The European Medicines Agency (EMA) has authorized lorlatinib as a monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.
This statement is based on a regulatory approval from the European Medicines Agency:
Lorviqua as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or crizotinib and at least one other ALK TKI.