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36356711000001105

New Medicines

Braftovi Previously untreated BRAF V600E-mutant metastatic colorectal cancer - in combination with cetuximab

Information

Braftovi
Licence extension / variation
Pierre Fabre
Array BioPharma

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Suppresses the RAF-MEK-ERK pathway in tumour cells expressing B-RAF600E. Taken orally once daily, and cetuximab is given by IV infusion every 2 weeks.
Colorectal cancer is the third most common cancer in the UK after breast and lung cancer, with approximately 40,000 new cases registered each year. Colorectal cancer is the second most common cause of cancer death in the UK. Age-standardised incidence rate per 100,000 population in the UK in 2008 was 47.2 (29.4 colon, 17.8 rectum) [1].
Previously untreated BRAF V600E-mutant metastatic colorectal cancer - in combination with cetuximab
Oral

Braftovi Metastatic or unresectable locally advanced BRAF-mutant malignant melanoma - with binimetinib and pembrolizumab

Information

Braftovi
Licence extension / variation
Pierre Fabre
Array BioPharma

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

BRAF kinase inhibitor taken orally once daily, with binimetinib (oral MEK inhibitor) taken twice daily and pembrolizumab (PD-1 inhibitor) given by IV infusion
In 2011, the UK age-standardised incidence of melanoma for females was 17.6 (11.7 in 2001) and for males 17.5 (10.1 in 2001) per 100,000 population. BRAF is a serine/threonine protein kinase activating the MAP kinase/ERK-signalling pathway. It is encoded on chromosome 7q34. About 50% of melanomas have activating BRAF mutations [1].
Metastatic or unresectable locally advanced BRAF-mutant malignant melanoma - with binimetinib and pembrolizumab
Oral