Braftovi (encorafenib)
- Region
- 🇪🇺 EU
- Active substance
- encorafenib
- Company
- Pierre Fabre Medicament
- Status
- Authorised
- Therapeutic area
- Melanoma; Colorectal Neoplasms
- CHMP opinion
- Thu 26 Jul 2018
- EU approval
- Wed 19 Sep 2018
- Application
- EMEA/H/C/004580
- ATC
- L01EC03
- Official record
- www.ema.europa.eu
Indication
MelanomaEncorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Colorectal cancer (CRC)Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy. Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation. Non-small cell lung cancer (NSCLC)Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.
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.