The European Medicines Agency (EMA) has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for BRAFV600E-mutant metastatic colorectal cancer (mCRC).

The combination, which also includes cetuximab, has the potential to be the first chemotherapy-free, targeted regimen for patients with advanced colorectal cancer if it is approved.

The company revealed that the application was based on data from the pivotal Phase III BEACON CRC trial, which evaluated the efficacy and safety of BRAFTOVI+MEKTOVI in combination with cetuximab in patients with advanced BRAFV600E-mutant mCRC whose disease has progressed after one or two prior lines of therapy.

The study, a first-of-its-kind, is designed to test combined BRAF/MEK targeted therapies in individuals with BRAF-mutant mCRC. It ultimately found that the combination showed significant improvements in overall survival (OS) and objective response rates (ORR) compared with cetuximab plus irinotecan-containing regimens.

The BRAF-mutant variation of the disease is “devastating”, with “currently limited treatment options that can prolong the lives of patients” explained Jean-Luc Lowinski, chief executive officer of the Pierre Fabre Pharmaceuticals Division

The acceptance of our application by the EMA brings us one step closer to realising our commitment towards advancing care for patients living with difficult-to-treat cancers. If approved, BRAFTOVI+MEKTOVI in combination with cetuximab has the potential to be the first chemotherapy-free, targeted regimen for patients with BRAFV600E-mutant mCRC.”

Patients with BRAF-mutant CRC generally have a poor prognosis with current available treatments as currently, there are no approved therapies in Europe specifically indicated for this high medical need population.

The National Institute for Health and Care Excellence (NICE) recommended the combo as an option for some people with melanoma back in January 2019, making the meds available to adults with BRAF V600 mutation-positive melanoma, that cannot be removed surgically or that has spread to nearby organs.

Worldwide, colorectal cancer is the third most common type of cancer in men and the second most common in women, with approximately 1.8 million new diagnoses in 2018.