EU grants approval of Lorviqua in ALK-positive advanced non-small cell lung cancer.

The approval for the first-line use of Lorviqua was based on the results of the pivotal Phase III CROWN trial, in which Lorviqua reduced the risk of disease progression or death by 72% compared to Xalkori (crizotinib). As a secondary endpoint, the confirmed objective response rate (ORR) was 76% (95% CI, 68 to 83) with Lorviqua and 58% (95% CI, 49 to 66) with Xalkori. In patients with measurable brain metastases, 82% of patients in the Lorviqua arm experienced an intracranial response (71% had an intracranial complete response), compared to 23% of Xalkori patients. The CROWN trial is a randomized, open-label, parallel 2-arm trial in which 296 people with previously untreated advanced ALK-positive NSCLC were randomized 1:1 to receive Lorviqua monotherapy (n=149) or Xalkori monotherapy (n=147).

In 2019, the EC granted conditional marketing authorization for Lorviqua as a monotherapy 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.