Kyprolis (carfilzomib)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- carfilzomib
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Multiple Myeloma
- CHMP opinion
- Thu 24 Sep 2015
- EU approval
- Thu 19 Nov 2015
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/003790
- ATC
- L01XX45
- Official record
- www.ema.europa.eu
Indication
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior 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.