CABOMETYX® approved by the European Commission

CABOMETYX® approved by the European Commission
May 28, 2018 Sofie Svendsen
In News

On the 17th of May, 2018, Cabometyx® (cabozantinib) was approved by the European Commission for the first-line treatment of adult patients with intermediate- or poor-risk advanced renal cell carcinoma (aRCC).

In September 2016, Cabometyx® was firstly approved by the European Commission as treatment for adult patients with advanced RCC who have received prior vascular endothelial growth factor (VEGF)-targeted therapy. As such, this newest approval marks the second for Cabometyx® from the European Commission in the kidney cancer setting.

As established in an earlier article, renal cell carcinoma is cancer in the kidney(s). It is by far the most common type of kidney cancer (app. 9 in 10 cases).

The latest approval from the European Commission

The approval of Cabometyx® (cabozantinib) in this new kidney cancer setting was based on a clinical trial called CABOSUN. In the trial, Cabometyx® was compared with the current standard of care (Sutent ® – sunitinib). The results of the trial met the primary endpoint by illustrating a statistically and clinically meaningful improvement in terms of progression-free survival. Here, Cabometyx® demonstrated a median progression-free survival of 8.6 months compared to 5.3 months for Sutent ® (sunitinib).

With this approval for first-line treatment from the European Commission, Cabometyx® can possibly go head to head with the immuno-oncology combination therapy described in an earlier article, namely Opdivo® (nivolumab) + Yervoy® (ipilimumab) – if this combination therapy gets approved by the European Commission too. The combination was approved in the exact same setting as Cabometyx® last month by the US FDA.

Cabozantinib –  Cabometyx® and Cometriq®

Cabozantinib is not only approved under the brand name Cabometyx®, but also under the brand name Cometriq®. In Europe, Cometriq® is approved for the treatment of adult patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer. As such, the medicine is approved for two different settings.

 

If you have any questions regarding cabozantinib – both Cabometyx® and Cometriq®, please contact us here

 

Cabometyx® (cabozantinib) is a registered trademark of Ipsen/Exelixis.

 

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