A Treatment Option for Metastatic Colorectal Cancer Patients with BRAFV600E Mutation in Singapore

• BRAFTOVI in combination with cetuximab has been included on MOH CDL, for patients with BRAFV600E-mutant metastatic colorectal cancer who have received prior systemic therapy.
• Singaporeans & Permanent Residents can claim using MediShield Life and withdraw from MediSave from their CPF accounts.

SINGAPORE  – 18 December 2023 – Pierre Fabre Singapore receives approval from the Ministry of Health (“MOH”), Singapore, for the listing of BRAFTOVI on the Cancer Drug List (“CDL”).¹

An approved therapeutic product registered with Health Sciences Authority,² BRAFTOVI, in combination with cetuximab, has been indicated in CDL as a treatment for adult patients with BRAFV600E-mutant¹ metastatic colorectal cancer (“mCRC”). These patients must have had prior systemic therapy.¹

BRAF mutations are estimated to occur in approximately 8–12% of patients with mCRC, and V600E is the most common mutation.^3-11 Patients with mCRC who have BRAFV600E-mutant tumours generally have a poor prognosis and therefore represent an unmet medical need.¹² Currently, there are no other approved targeted treatments in Singapore specifically indicated for this patient population.¹

BRAFTOVI (encorafenib) is an oral small-molecule BRAF kinase inhibitor that targets a key enzyme in the MAPK signalling pathway (RAS-RAF-MEK-ERK). Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, including melanoma and colorectal cancer.

The BRAFTOVI and cetuximab combination regimen represents an option to treat BRAFV600E-mutant mCRC patients after prior systemic therapy. According to the Phase 3 BEACON CRC trial, a randomised Phase 3 trial designed to investigate a BRAF combination targeted therapy in BRAFV600E-mutant mCRC, BRAFTOVI in combination with cetuximab significantly improved overall survival in patients with BRAFV600E-mutant mCRC and reduced the risk of death by 40%.¹³

The Phase 3 BEACON CRC trial demonstrated a well-tolerated safety profile with no unexpected toxicities in the trial. The most common adverse drug reactions (>25%), observed in the BEACON CRC trial, were fatigue, nausea, diarrhoea, dermatitis acneiform, abdominal pain, arthralgia/musculoskeletal pain, decreased appetite, rash and vomiting.^{2, 13}

In Singapore, there are no other approved targeted treatments specifically indicated for this mCRC BRAFV600E-mutant patient population.¹ Such patients who are Singaporeans or Singapore Permanent Residents can claim MediShield Life of up to SGD1,800 per month, and withdraw from MediSave of up to SGD600 per month from their Central Provident Fund (“CPF”) accounts.¹

“The approval of BRAFTOVI for its indication in Singapore reflects our long-term commitment to advancing care for patients living with difficult-to-treat cancers,” said Mr. Jairo Pardey, General Manager, Pierre Fabre Singapore. “Listed on the Cancer Drug List by Ministry of Health, Singapore, the BRAFTOVI and cetuximab combination targeted regimen provides an option as a cost-effective cancer drug treatment for this population.”

Colorectal cancer is one of the most common cancers among males and female aged 50 years and above in Singapore.¹⁴ According to Singapore Cancer Registry Annual Report, it is the second deadliest cancer in Singapore and the mortality rate of colorectal cancers had risen from 2.9 to 13.0 per 100,000 from 1968 to 2020.¹⁵ Singapore Cancer Society also reports an increasing trend of colorectal cancer among young adults.¹⁴