Jemperli (dostarlimab)
- Region
- 🇪🇺 EU
- Active substance
- dostarlimab
- Company
- GlaxoSmithKline Trading Services Limited
- Status
- Authorised
- Therapeutic area
- Endometrial Neoplasms
- CHMP opinion
- Thu 25 Feb 2021
- EU approval
- Wed 21 Apr 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005204
- ATC
- L01FF07
- Official record
- www.ema.europa.eu
Indication
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.
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.