Scemblix (asciminib)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- asciminib
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- CHMP opinion
- Thu 23 Jun 2022
- EU approval
- Thu 25 Aug 2022
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005605
- ATC
- L01EA06
- Official record
- www.ema.europa.eu
Indication
Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP). Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).
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.