Lorviqua (lorlatinib)
- Region
- 🇪🇺 EU
- Active substance
- lorlatinib
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 28 Feb 2019
- EU approval
- Mon 06 May 2019
- Application
- EMEA/H/C/004646
- ATC
- L01ED05
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.