Alecensa (alectinib)
- Region
- 🇪🇺 EU
- Active substance
- alectinib
- Company
- Roche Registration GmbH
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 15 Dec 2016
- EU approval
- Thu 16 Feb 2017
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004164
- ATC
- L01ED03
- Official record
- www.ema.europa.eu
Indication
Adjuvant treatment of resected non small cell lung cancer (NSCLC) Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK positive NSCLC at high risk of recurrence (see section 5.1 for selection criteria).Treatment of advanced NSCLCAlecensa as monotherapy is indicated for the first line treatment of adult patients with ALK positive advanced NSCLC.Alecensa as monotherapy is indicated for the treatment of adult patients with ALK positive advanced NSCLC previously treated with crizotinib.
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.