First targeted therapy PBS listed for metastatic bowel cancer patients with BRAF gene mutation

Pharma News: Pierre Fabre Australia announced that BRAFTOVI (encorafenib) in combination with cetuximab is listed on the PBS (Pharmaceutical Benefits Scheme) from 1 January 2022 for the treatment of metastatic bowel cancer patients with a BRAF^V600 mutation following failure to respond to at least one prior systemic therapy.                                   

In Australia, BRAF gene mutations occur in approximately 13-15% of patients with metastatic bowel cancer, with V600E being the most common mutation. Patients with metastatic bowel cancer who have a BRAF^V600 mutation tend to have less success with chemotherapy. Until now, there were no approved targeted treatments in Australia specifically indicated and reimbursed for this patient population.

Minister for Health and Aged Care, Greg Hunt, said this listing will benefit around 340 Australians a year.

“Without this subsidy, patients might pay more than $33,600 per course of treatment,” Minister Hunt said.

Julien Wiggins, CEO of Bowel Cancer Australia, welcomed the availability of BRAFTOVI on the PBS for this subset of cancer patients “This announcement will deliver life-extending benefits for patients with the BRAF^V600 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 BRAF^V600mutation.

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 BRAF^V600-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.”

Gemma Farquhar was diagnosed with bowel cancer in April 2020, at the age of 35 and 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.”

“This 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 1^st January 2022.”

Over 15,000 Australians are diagnosed with bowel cancer each year, and it claims over 5,000 lives per year. Bowel cancer is the second deadliest cancer in Australia and the fifth leading cause of death of Australians aged 25-44.