Lorlatinib
Lorlatinib (Lorviqua, Pfizer Europe MA EEIG) has 2 EU-approved indications in 1 tumour type. Each needs a biomarker result: ALK (2).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Non-small cell lung cancer2 | |||
ALK fusion | Monotherapy | 2L advanced | 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 |
ALK fusion | Monotherapy | Any line advanced | Previously not treated with an ALK inhibitor |
Full text of section 4.1 (therapeutic indications)
Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. Lorviqua as monotherapy is indicated 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.
Label history
17 changes to the Lorviqua label since 2020, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes