Krazati (adagrasib)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- adagrasib
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 09 Nov 2023
- EU approval
- Fri 05 Jan 2024
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/006013
- ATC
- L01XX77
- Official record
- www.ema.europa.eu
Indication
Krazati as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior 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.