Combination treatment (Pr)Tafinlar® (dabrafenib) plus (Pr)Mekinist® (trametinib) approved by Health Canada to treat BRAF V600- positive metastatic non-small cell lung cancer (NSCLC) after prior systemic therapy
Only approved targeted therapy combination for patients with BRAF V600-positive NSCLC
Dorval, Quebec, June 15, 2017 – A combination oral drug treatment from Novartis has been approved by Health Canada to treat a form of non-small cell lung cancer (NSCLC). Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) has been approved for the treatment of patients with metastatic NSCLC with a BRAF V600 mutation whose disease has progressed following systemic therapy. It is estimated that about 1-3% of Canadians with NSCLC are BRAF V600-positive, a population who previously had few treatment options.
“We are very pleased to be able to offer a new treatment option to this specific population of Canadians with lung cancer,” said Winselow Tucker, General Manager of Novartis Canada Oncology. “We recognize the significance of this news for the lung cancer community. Novartis remains committed to ongoing research and development of new innovative therapies to meet the needs of Canadians with various types of cancer.”
Tafinlar® and Mekinist® target different proteins, BRAF and MEK1/2 respectively, from a signaling pathway which is implicated in NSCLC and melanoma. When Tafinlar® is used with Mekinist®, the combination has been shown to slow tumor growth more than either drug alone,.
“As we learn more about the different types of lung cancer and their specific molecular and genetic nature, targeted therapies become vital to have the best chance of treatment success,” said Dr. Barbara Melosky, medical oncologist at the BC Cancer Agency. “This new combination treatment has shown promising results in clinical studies and gives patients hope and an important new option where before the treatments were limited.”
Lung cancer is by far the deadliest cancer in Canada, claiming almost 21,000 Canadians in 2016, more than colorectal, breast and prostate cancer combined.
“The availability of a targeted therapy specifically for NSCLC patients with a BRAF V600 mutation is great news,” said Shem Singh, Executive Director, Lung Cancer Canada. “New treatments give cancer patients and their families a chance to live and spend more quality time together. Health Canada approval is the first step. We hope Canadians who stand to benefit from this combination treatment can get access and have the chance it offers."
About Tafinlar® + Mekinist® Combination The Tafinlar® + Mekinist® combination was previously approved for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation. Tafinlar® and Mekinist® are also indicated as single agents to treat patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
The combination of Tafinlar® + Mekinist® is currently being investigated in an ongoing clinical trial program across a range of tumor types conducted in study centers worldwide. The safety and efficacy profile of the Tafinlar® + Mekinist® combination has not yet been established outside of the approved indications.
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 2016, the company invested $48.8 million in 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 www.novartis.ca.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
 Novartis Pharmaceuticals Canada Inc., Product Monograph for Tafinlar® (dabrafenib), May 15, 2017, p. 3-4 and Product Monograph for Mekinist® (trametinib), May 15, 2017, p. 3-4.
 Pao W, Girard N. New driver mutations in non-small-cell lung cancer. 2011. Lancet Oncol. 12: 175–180.  Planchard D et al, Dabrafenib plus trametinib in patients with previously treated BRAF-V600E-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial, Lancet Oncology, published online June 6, 2016, http://dx.coi.org/10.1016/S1470-2045(16)30146-2  Caparica R, de Castro G, Jr., Gil-Bazo I, et al. BRAF mutations in non-small cell lung cancer: has finally Janus opened the door? Crit Rev Oncol Hematol. 2016; 101:32-9. http://dx.doi.org/10.1016/j.critrevonc.2016.02.012  Flaherty, KT, Infante, JR, C, Daud, A, et al. Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations. New England Journal of Medicine. 2012.  Canadian Cancer Society, Canadian Cancer Statistics 2016, p. 50. Accessed May 16, 2017, at: http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20...