Pierre Fabre has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the use of Braftovi (encorafenib) and Mektovi (binimetinib) combination to treat melanoma.

The indication covers treatment of adults suffering from unresectable or metastatic melanoma with a BRAFV600 mutation.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Braftovi is an oral small-molecule inhibitor of BRAF kinase, while Mektovi blocks MEK that targets enzymes in the MAPK signalling pathway.

Pierre Fabre Pharmaceuticals division president & CEO Frédéric Duchesne said: “We are delighted to be one step closer to bringing Braftovi and Mektovi to patients with advanced BRAF-mutant melanoma in Europe.

“If the European Commission approves Braftovi and Mektovi, this will be a new treatment option for these patients who currently have a challenging prognosis.”

The CHMP’s positive opinion comes after review of results from the Phase III Columbus clinical trial conducted to assess the safety and efficacy of the combination therapy in a total of 921 subjects at more than 200 sites across North and South America, Europe, Asia, Africa and Australia.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
“If the European Commission approves Braftovi and Mektovi, this will be a new treatment option for these patients who currently have a challenging prognosis.”

During the two-part, international, randomised, open-label trial, the Braftovi and Mektovi combination was compared with vemurafenib and encorafenib monotherapy.

Results showed improved median progression-free survival (PFS) of 14.9 months with the combination therapy, compared to 7.3 months using vemurafenib alone.

The median overall survival (OS) in patients treated with the combination was found to be 33.6 months, compared to 16.9 months in those administered with vemurafenib.

Pierre Fabre has exclusive rights to develop and commercialise Braftovi and Mektovi in all countries, except the US, Canada, Israel, Japan and South Korea.

The US and Canadian rights for the drugs are held by Array BioPharma. Medison has the exclusive rights in Israel, and Ono Pharmaceutical in Japan and South Korea.