PBS listing for BRAFTOVI + cetuximab for metastatic bowel cancer patients with BRAFV600 mutation

Pierre Fabre

The approval of BRAFTOVI in combination with cetuximab provides a targeted therapy regimen specifically for Australian metastatic bowel cancer patients with a BRAFV600E-mutation 2,3

Sydney, Australia, 30 December 2021: Pierre Fabre Australia today announced that BRAFTOVI (encorafenib) in combination with cetuximab will be listed on the PBS (Pharmaceutical Benefits Scheme) from 1 January 2022 for the treatment of metastatic bowel cancer patients with a BRAFV600 mutation following failure to respond to at least one prior systemic therapy.1

In Australia, BRAF gene mutations occur in approximately 13-15% of patients with metastatic bowel cancer,4-6 with V600E being the most common mutation.7 A mutation in the BRAF gene instructs the body to make a protein that is not found in healthy organs, which increases the growth and spread of cancer cells.8 Patients with metastatic bowel cancer who have a BRAFV600 mutation tend to have less success with chemotherapy.8,9 Until now, there were no approved targeted treatments in Australia specifically indicated and reimbursed for this patient population.1-3

Julien Wiggins, CEO of Bowel Cancer Australia, welcomed the availability of BRAFTOVI on the PBS for this subset of cancer patients: “Today’s announcement will deliver life-extending benefits for patients with the BRAFV600 mutation, so they can continue doing the things that matter most to them, whether it’s spending time with family and friends, working, volunteering or travelling.”

This PBS listing is based on results from the BEACON CRC trial, the only Phase 3 trial to date to specifically study patients with previously treated metastatic bowel cancer with a BRAFV600mutation.2,8,10 The most common adverse drug reactions (>25%) observed in the BEACON CRC trial were fatigue, diarrhoea, nausea, abdominal pain, dermatitis acneiform, arthralgia/musculoskeletal pain, decreased appetite, rash and vomiting.2

Welcoming the news, Associate Professor Jayesh Desai, Medical Oncologist at the Peter MacCallum Cancer Centre and a lead investigator on the BEACON CRC trial said, “Patients will now have access, for the very first time, to a targeted therapy specifically for BRAFV600-mutant mCRC, a result of dedicated research to deliver precision medicine. The BRAFTOVI and cetuximab combination regimen will be practice-changing, providing a much-needed new treatment option for this high medical need population.”

Over 15,000 Australians are diagnosed with bowel cancer each year, and it claims over 5,000 lives per year.11 Bowel cancer is the second deadliest cancer in Australia and the fifth leading cause of death of Australians aged 25-44.11 The incidence of bowel cancer in Australians under the age of 50 increased 2.9% per year between Jan 1995 and Dec 2012.12

Gemma Farquhar was diagnosed with bowel cancer in April 2020, at the age of 35: “With two young children aged 4 and 6 – bowel cancer was the last thing on my doctor’s mind, but I knew something wasn’t right. I had never even considered bowel cancer as a possibility for someone as healthy and young as I was, I honestly just viewed it as an old person’s disease.”

In June 2020, Gemma learned that she carried the BRAF mutation: “There were limited treatment options apart from standard chemo, which doesn’t necessarily work for long with this particular mutation. Having this available on the PBS is a milestone that I and many others have been waiting for and is worth celebrating.”

“Today’s approval reflects our long-term commitment to advancing care for patients living with difficult-to-treat cancers,” said Laurent-Emmanuel Saffré, CEO Pierre Fabre Australia. “We commend the Federal Government for making this much-needed treatment available on the Pharmaceutical Benefits Scheme from 1st January 2022.”

About BRAFTOVI (encorafenib)

BRAFTOVI (encorafenib) is an oral (capsule) BRAF inhibitor, which blocks the activity of the BRAF protein in a signalling pathway for cancer.13 Inappropriate activation of proteins in this signalling pathway has been shown to occur in many cancers, including melanoma,14 colorectal,15 thyroid,16 non-small cell lung cancer17 and others.18

About Pierre Fabre

The Pierre Fabre Group, founded by pharmacist Pierre Fabre, is the second largest private pharmaceutical company in France. Owned by a government recognised public interest foundation, the Group is committed to designing and developing innovative solutions to contribute to the wellbeing of everyone through products across consumer health, dermo-cosmetics and pharmaceuticals.

In Australia, Pierre Fabre has prescription medicines in the area of oncology, dermo-cosmetics brand Eau Thermale Avène (a skincare range for all forms of sensitive skin), and Klorane (a haircare range formulated from carefully selected botanical ingredients).

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