Novartis receives Health Canada approval for the combination therapy of Tafinlar® (dabrafenib) plus Mekinist® (trametinib) for adjuvant treatment of patients with BRAF V600 mutation melanoma(i)

  • Targeted treatment aims to prevent cancer recurrence following tumour removal by surgery
  • First approval in Canada of an adjuvant treatment for melanoma (BRAF V600 mutated)
  • Ongoing development of melanoma combination treatment a testament to the Novartis commitment to reimagine cancer care

DORVAL, QC, Nov. 1, 2018 /CNW/ – Novartis is pleased to announce that Health Canada has approved the use of a combination of two Novartis cancer therapies as targeted treatment to prevent recurrence of melanoma following surgery, also referred to as adjuvant treatment. The combination of Tafinlar® (dabrafenib) and Mekinist® (trametinib) has been approved for the adjuvant treatment of patients with BRAF V600 mutation melanoma and involvement of lymph nodes, following complete surgical removal of the tumoursi.

Melanomas in which tumour cells have spread to the lymph nodes near the original skin tumour are called stage III melanomas and present a higher risk of recurrence or spreading to a different part of the body (metastasis)ii. These patients are typically treated with surgery to remove the tumoursiii. Adjuvant therapy is a significant option to reduce relapses for melanoma patients following surgeryiv. The combination therapy is specifically targeted to, and indicated for, the BRAF V600 mutation of melanoma, once the presence of the mutation has been verified by required testingi.

“Novartis is very pleased to bring this targeted combination therapy to Canadians with this serious form of skin cancer,” said Isabelle Deslauriers, Franchise Head, Solid Tumours, Oncology, Novartis Pharmaceuticals Canada Inc. “Part of our commitment to reimagine cancer care is the ongoing development of our innovative therapies. One out of every two Canadians will get cancer in their lifetimev  and we are committed to bringing new options, so they may live longer and better lives.”

The approval of the combination is based on results from the Phase III COMBI-AD global study, which enrolled more than 870 patients with stage III, BRAF V600E/K-mutant melanoma.

“There is a high risk of recurrence in patients with stage III melanoma who have lymph node involvement following surgery. The use of adjuvant dabrafenib and trametinib in patients with the BRAF V600 mutation halves the risk of relapse in three years, compared to watching and waitingiv,” said Dr. David Hogg of the Cancer Clinical Research Unit at Princess Margaret Cancer Centre, Toronto, and Professor of Medicine, University of Toronto. “This is another step forward in the management of this very serious cancer.”

Combination use of Tafinlar® plus Mekinist® is already approved by Health Canada to treat patients with unresectable or metastatic melanoma who have a BRAF V600 mutationi.

Tafinlar® (dabrafenib) + Mekinist® (trametinib) Important Safety Information
The full prescribing information for Tafinlar® and Mekinist® can be found at:

Novartis Commitment to Oncology
At Novartis, our mission is to discover new ways to help improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop innovative treatments and find new ways to deliver them to as many people as possible. We strive to change the practice of medicine. We aspire to approach things differently – to make discoveries that take medicine in new directions. We look to tomorrow to inspire us today. Never satisfied with the status quo, we imagine what’s next.

As one of the leading pharmaceutical companies in oncology, Novartis globally offers a portfolio of more than 20 approved therapies and approximately 30 compounds in development. We are passionate about what we do and the impact we have on patients and societies. We are Novartis, and we are reimagining medicine.

About Novartis Pharmaceuticals Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2017, the company invested $51 millionin research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 750 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 1 billion people globally and we are finding innovative ways to expand access to our latest treatments. About 125,000 people of more than 140 nationalities work at Novartis around the world. Find out more at