Copiktra (duvelisib)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- duvelisib
- Company
- Secura Bio Limited
- Status
- Withdrawn
- Therapeutic area
- Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular
- CHMP opinion
- Thu 25 Mar 2021
- EU approval
- Wed 19 May 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005381
- ATC
- L01EM04
- Official record
- www.ema.europa.eu
Indication
Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies. Follicular lymphoma (FL) that is refractory to at least two prior systemic therapies.
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.