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Cabometyx (cabozantinib)

Region

🇪🇺 EU

Active substance

cabozantinib

Company

Ipsen Pharma

Status

Authorised

Therapeutic area

Carcinoma, Renal Cell; Carcinomas, Hepatocellular

CHMP opinion

Thu 21 Jul 2016

EU approval

Fri 09 Sep 2016

Designations

Accelerated assessment

Application

EMEA/H/C/004163

ATC

L01EX07

Official record

www.ema.europa.eu

Indication

Renal Cell Carcinoma (RCC) Cabometyx is indicated as monotherapy for advanced renal cell carcinoma as first-line treatment of adult patients with intermediate or poor risk, in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults. Hepatocellular carcinoma (HCC)Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.Differentiated thyroid carcinoma (DTC)Cabometyx is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.Neuroendocrine Tumours (NET)Cabometyx is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Cometriq Authorised · Ipsen Pharma
• 🇺🇸 Omcazio Approved · Handa Oncol

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.