Idelalisib
Idelalisib (Zydelig, Gilead Sciences Ireland UC) has 3 EU-approved indications in 2 tumour types. 1 needs a biomarker result: TP53/del(17p) (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Chronic lymphocytic leukaemia2 | |||
17p deletion or TP53 mutation | + rituximab | 1L | Not eligible for any other therapies |
None | + rituximab | 2L | After at least one prior therapy |
| Follicular lymphoma1 | |||
None | Monotherapy | 3L+ | Refractory to two prior lines of treatment |
Full text of section 4.1 (therapeutic indications)
Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): • who have received at least one prior therapy (see section 4.4), or • as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4). Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment (see section 4.4).
Label history
26 changes to the Zydelig label since 2016, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes