This approval reinforces the positioning of lorlatinib, a third generation ALK inhibitor, designed to overcome the brain barrier, lung cancer, diagnosed in more than two million people in 2018, continues to be the type of cancer Most common around the world. To the diagnosis, approximately 75 percent of all of them are already in advanced states of the disease. In addition, around 85 percent of all lung cancers belong to the typology of non-small cells and, of them, between 3 percent and 5 percent of cases present ALK translocation.
Precisely for these patients, the European Commission has approved lorlatinib, on a conditional basis, in monotherapy as treatment for adult patients with non-small advanced ALK positive lung cancer, whose disease has progressed after Treatment with alectinib or ceritinib as the first ALK inhibition therapy, or crizotinib and at least one more ALK inhibitor.
This decision is backed by the results of a non-randomized phase 1 and 2 B7461001 clinical study, with dose escalation and activity estimation, multiple and multicenter cohort, which showed the results of the lorlatinib administration in a total of 139 Patients with ALK-positive NMSC previously treated with at least one second-generation ALK inhibitor.
In particular, the overall response rate was 42.9 percent in those previously treated with a ALK inhibitor, and 39.6 percent in those previously treated with two or more inhibitors. 67 percent of patients had cerebral metastases.
In the words of Cecilia Guzmán, medical director of the oncology unit of Pfizer Spain, “We are excited about this approval because it is the second Pfizer drug for non-small lung cancer approved in less than two months and the third with Biomarkers for this pathology ”
The approval of lorlatinib implies an advance in the treatment of NMSC ALK +, although it is noteworthy that it has a conditional character, because, although the data obtained in its development phase are less numerous than is required in the processes of APROBAC General Ion, this medicine covers an urgent need in the approach of the disease in which the balance between benefit and risk is positive and the immediate availability of the medicine is highly positive.
That is why, in this framework of approval, Pfizer undertakes to provide additional data on post-authorisation clinical studies, including the Phase 3 CROWN, which is underway and evaluates lorlatinib against crizotinib in the first line treatment of patients With NMSC ALK +.