Array BioPharma has received breakthrough therapy designation from the US Food and Drug Administration (FDA) to use encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab for the treatment of metastatic colorectal cancer (mCRC).

The indication covers patients with BRAFV600E-mutant mCRC as identified using an US Food and Drug Administration (FDA)-approved test, following no response to one or two previous lines of therapy.

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BRAFV600E-mutant mCRC patients are at high mortality risk compared to people who have non-mutated mCRC. Currently the mutated type of mCRC lacks specifically approved treatments.

Braftovi is an oral small molecule inhibitor of BRAF kinase, while Mektovi inhibits MEK. The drugs target critical enzymes associated with the MAPK signalling pathway (RAS-RAF-MEK-ERK).

Array BioPharma chief medical officer Victor Sandor said: “As there are no regimens approved specifically for BRAFV600E-mutant mCRC, this designation provides us with the opportunity to work closely with the FDA to potentially accelerate our effort to bring an important treatment option to these patients in critical need.”

“This designation provides us with the opportunity to potentially accelerate our effort to bring an important treatment option those in critical need.”

In the latest Phase III BEACON CRC clinical trial, the combination therapy demonstrated 62% overall survival rate at one year, eight months of median progression-free survival (mPFS) and 48% overall response rate (ORR).

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The randomised, open-label, global trial is designed to assess the safety and efficacy of the triple combination therapy in 30 BRAFV600E-mutant mCRC patients whose disease progressed after one or two prior regimens.

Primary endpoint of the study, which is ongoing at more than 200 centres, is overall survival. The secondary endpoints include efficacy, PFS, ORR, duration of response, safety and tolerability.

Array holds exclusive rights to both Braftovi and Mektovi in the US and Canada.

Braftovi and Mektovi’s marketing authorisations are currently being reviewed by the European Medicines Agency, the Swiss Medicines Agency and the Australian Therapeutic Goods Administration. While the Pharmaceuticals and Medical Devices Agency in Japan is considering a manufacturing and marketing approval for the two drugs.