FDA approves supplemental New Drug Application (sNDA) for lorlatinib as first-line treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer

The expanded approval for this third-generation ALK inhibitor is based on data from phase 3 CROWN trial showing reduction in risk of progression or death vs. crizotinib in a previously untreated patient population (HR 0.28: 95% CI, 0.19 to 0.41; p<0.0001)

SPS commentary:

In UK, lorlatinib is currently licensed for the treatment patients 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.

Biospace Inc.