Lorlatinib (1) – Lorviqua®

• Clinical trials
  • To demonstrate the additional benefit, the pharmaceutical manufacturer has drawn on data from the international, multicentre, open-label Phase I/II registration trial B7461001.

a) Patients with ALK-positive, advanced NSCLC whose disease has progressed following treatment with alectinib or ceritinib as first-line ALK-TKI therapy, or with crizotinib and at least one other ALK-TKI; for whom further systemic antineoplastic therapy is an option

• An additional benefit is not proven
• The pharmaceutical manufacturer does not present any results in the dossier from directly comparative studies or studies suitable for an adjusted indirect comparison. Based on this evidence, it is not possible to infer any additional benefit for the two patient populations.
• The additional benefit of lorlatinib in the treatment of patients with ALK-positive, advanced NSCLC whose disease has progressed following alectinib or ceritinib as first-line ALK-TKI therapy, or crizotinib and at least one other ALK-TKI; whether or not they are eligible for further systemic antineoplastic therapy, is not proven.

b) Patients with ALK-positive, advanced NSCLC whose disease has progressed following treatment with alectinib or ceritinib as first-line ALK-TKI therapy, or with crizotinib and at least one other ALK-TKI; for whom further antineoplastic systemic therapy is not an option

• An additional benefit is not proven
• The pharmaceutical manufacturer does not present any results in the dossier from direct comparative studies or studies suitable for an adjusted indirect comparison. On the basis of this data, it is not possible to infer any additional benefit for the two patient populations.
• The additional benefit of lorlatinib in the treatment of patients with ALK-positive, advanced NSCLC whose disease has progressed following alectinib or ceritinib as first-line ALK-TKI therapy, or crizotinib and at least one other ALK-TKI; for whom further systemic antineoplastic therapy is an option or for whom further systemic antineoplastic therapy is not an option, it is not proven.

Courtesy translation only, please refer to the German original.