Pierre Fabre's Braftovi (encorafenib) has been approved in Europe for use alongside Erbitux (cetuximab) to treat of adults with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy.
Currently, there are no other licensed targeted regimens in Europe indicated for this specific patient population.
Marketing clearance comes after the combination significantly improved median overall survival (OS) in patients with BRAFV600E-mutant mCRC (9.3 months vs 5.9 months) and reduced the risk of death by 39% compared to the control arm (cetuximab plus irinotecan).
The Phase III BEACON CRC trial also reported an improved objective response rate (20% vs 2%;), compared to the control arm.
Approval of the combination “represents a major milestone for metastatic colorectal cancer patients, with a BRAFV600E mutation, since we are now able to combine two specific, targeted therapies without the need for any conventional, cytotoxic chemotherapy,” said Dr Harpreet Wasan, consultant oncologist, London and BEACON chief investigator in the UK.
“Conventional, cytotoxic chemotherapy is associated with suppression of the immune system and so this chemotherapy-free option is particularly relevant in the current COVID-19 climate; potentially also avoiding the use of permanent indwelling venous catheters, with the aim of reducing patient visits to hospitals.
“Currently in the UK, there are no available treatments specifically targeting BRAFV600E metastatic colorectal cancer,” Dr Wasan added, also noting that these patients generally have worse outcomes and a poor prognosis when treated with standard chemotherapy. The Braftovi/Erbitux combination “offers a significantly better option in their disease management.”
“Our hope now is that the significant benefits of this combination will be recognised by the UK for routine NHS availability; providing access to all our colorectal cancer patients, who show the BRAFV600E mutation,” added Sarah Stimpson, who trained originally as a nurse and is now a senior clinical research practitioner in the lead UK centre for the BEACON study.
Pierre Fabre said it has entered discussions with the National Institute for Health and Care Excellence (NICE) in England, the All Wales Medicines Strategy Group (AWMSG) in Wales and the Scottish Medicines Consortium (SMC) in Scotland to discuss the possibility of making the combination available on the NHS.