Lumykras (sotorasib)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- sotorasib
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Thu 06 Jan 2022
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005522
- ATC
- L01XX73
- Official record
- www.ema.europa.eu
Indication
Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.
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.