Zydelig (idelalisib)
- Region
- 🇪🇺 EU
- Active substance
- idelalisib
- Company
- Gilead Sciences Ireland UC
- Status
- Authorised
- Therapeutic area
- Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
- CHMP opinion
- Fri 25 Jul 2014
- EU approval
- Thu 18 Sep 2014
- Designations
- Additional monitoring
- Application
- EMEA/H/C/003843
- ATC
- L01XX47
- Official record
- www.ema.europa.eu
Indication
Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
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.