Novartis Oncology's Tafinlar® (Dabrafenib) and Mekinist® (Trametinib) Dual-Target Therapy Approved in China for BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma

Beijing, December 19, 2019 /PRNewswire/ -- The National Medical Products Administration announced today that Novartis Oncology’s dual-targeted combination therapy of dabrafenib (brand name Tafinlar®) and trametinib (brand name Mekinist®), indicated for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma, has received marketing approval in China.

Novartis Oncology also submitted an application at the beginning of the year for the combination therapy of Tafinlar® and Mekinist® as adjuvant treatment following complete resection of stage III melanoma with BRAF V600 mutation. Tafinlar® combined with Mekinist® is expected to become the first targeted therapy in China with dual indications for both advanced and adjuvant treatment of BRAF V600-mutant melanoma.

# The Diagnosis and Treatment of Melanoma in China Face Significant Unmet Needs

Melanoma is a highly malignant tumor originating from melanocytes, which can occur in various sites or tissues such as the skin, acral regions, mucous membranes (including the gastrointestinal, respiratory, and urogenital tracts), the uvea of the eye, and the leptomeninges. In China, there are approximately 20,000 new cases of melanoma annually, with both incidence and mortality rates showing a year-on-year upward trend. Due to low public awareness and a lack of standardized diagnosis and testing, most patients in China are diagnosed at intermediate or advanced stages. The five-year survival rate for these patients drops sharply compared to those diagnosed at an early stage (4.6% vs. 94%), imposing a significant economic burden on patients' families and society.

Among these, BRAF mutation is the most common type of genetic mutation in melanoma. In China, one in every four melanoma patients may have a BRAF V600 mutation. In recent years, the prognosis for melanoma treatment has significantly improved compared to the past, offering patients more therapeutic options, ranging from chemotherapy to targeted therapy and immunotherapy. Notably, targeted therapies for patients with BRAF-driven mutations have been proven to help improve progression-free survival and achieve long-term survival benefits.^[2]。

Tafinlar®and Majining®Dual-Drug Combination Therapy Represents the Era of Precision Medicine in Melanoma

Among the recently approved Tafinlar® and Mekinist®, Tafinlar® is a potent and selective inhibitor of BRAF kinase activity. Mekinist® (trametinib) is a reversible, highly selective allosteric inhibitor of MEK1 and MEK2 kinase activities. The combination therapy targets the driver mutations in BRAF V600 mutation-positive melanoma, leading to rapid and significant tumor regression and improved progression-free survival in patients. Results from multiple global pivotal clinical studies have shown that, compared with targeted monotherapy, the combination of Tafinlar® and Mekinist® helps patients with BRAF V600-mutant melanoma achieve higher disease response rates and longer progression-free survival.

Tafinlar® and Mekinist® have been approved for marketing in multiple countries and regions, including the United States, the European Union, Switzerland, Canada, and Japan. Over the past five years, more than 76,000 patients worldwide have benefited from these treatments. In 2019, the National Comprehensive Cancer Network (NCCN) Guidelines recommended their use for BRAF V600-positive metastatic or unresectable melanoma, as well as for adjuvant treatment of Stage III melanoma at high risk of recurrence. The 2019 revised China Society of Clinical Oncology (CSCO) Guidelines also included them as expert-recommended medications for the late-stage and adjuvant treatment of BRAF V600-positive melanoma.^[3,4]. The launch of the dual-drug combination therapy in China will benefit more Chinese melanoma patients, bringing them new hope.

Declaration:

[1]“Improved Overall Survival in Melanoma with Combined Dabrafenib and Trametinib” ,  November 16, 2014, The New England Journal of Medicine; “Combined BRAF and MEK Inhibition versus BRAF Inhibition Alone in Melanoma” , September 29, 2014, The new England Journal of Medicine; “Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations” , N Engl J Med. 2012 November ; 367(18): 1694–1703. doi:10.1056/NEJMoa1210093

[2] Robert C, et al. N Engl J Med. 2019;381:626-636

[3] Cutaneous Melanoma, Version 2.2019 J Natl Compr Canc Netw 2019;17(4):367–402

[4] Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Malignant Melanoma, 2019 Edition

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