Dostarlimab
Dostarlimab (Jemperli, GlaxoSmithKline Trading Services Limited) has 2 EU-approved indications in 1 tumour type. 1 needs a biomarker result: MMR/MSI (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Endometrial cancer2 | |||
None | + carboplatin and paclitaxel | 1L advanced | Candidates for systemic therapy |
MMR/MSI deficient | Monotherapy | 2L advanced | Progressed on or following prior treatment with a platinum-containing regimen |
Full text of section 4.1 (therapeutic indications)
JEMPERLI is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy. JEMPERLI is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/ microsatellite instability-high (MSI-H) recurrent or advanced EC that has progressed on or following prior treatment with a platinum-containing regimen.
Label history
20 changes to the Jemperli label since 2022, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes