Kisplyx (lenvatinib)
Accelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- lenvatinib
- Company
- Eisai GmbH
- Status
- Authorised
- Therapeutic area
- Carcinoma, Renal Cell
- CHMP opinion
- Thu 21 Jul 2016
- EU approval
- Thu 25 Aug 2016
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/004224
- ATC
- L01XE29
- Official record
- www.ema.europa.eu
Indication
Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC): in combination with pembrolizumab, as first-line treatment (see section 5.1). in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Lenvima Authorised · Eisai GmbH
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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.