Gavreto (pralsetinib)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- pralsetinib
- Company
- Blueprint Medicines (Netherlands) B.V.
- Status
- Withdrawn
- Therapeutic area
- Carcinoma, Non-Small-Cell Lung
- CHMP opinion
- Thu 16 Sep 2021
- EU approval
- Thu 18 Nov 2021
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/005413
- ATC
- L01EX23
- Official record
- www.ema.europa.eu
Indication
Gavreto is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
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.