European Commission has granted conditional approval for Loqviqua for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer as a monotherapy. The drug is indicated in patients whose disease has progressed after alectinib or ceritinib as first ALK tyrosine kinase inhibitor therapy. Loqviqua is a third-generation ALK tyrosine kinase inhibitor, which can penetrate the blood-brain barrier in spite of the resistant mutations.
The approval is based on multi-center Phase 1/2 study, B7461001. The study included 139 patients with ALK-positive advanced NSCLC, who had at least one second-generation ALK tyrosine kinase inhibitor (alectinib, brigatinib or ceritinib). The overall response rate was 42.9% for patients treated with one ALK tyrosine kinase inhibitor, 39.6% in patients who had two or more ALk tyrosine kinase inhibitors.
According to the conditional approval, Pfizer has to submit the Phase 3 CROWN data and additional information from post-marketing studies. In CROWn studies, Lorviqua is compared with crizotinib for the treatment of patients with ALK-positive NSCLC in the first line.