Tafinlar(dabrafenib)

Tafinlar (dabrafenib) is an approved drug with an FDA approval date for monotherapy on May 29, 2013. The Marketing Authorisation application was submitted on July 24, 2012, and a CHMP positive opinion was issued on June 27, 2013, leading to a granted Marketing Authorisation recommendation.

In clinical trials, Tafinlar demonstrated a median progression-free survival of 6.9 months, compared to 2.7 months, with a progression-free survival hazard ratio of 0.37. The overall response rate was 59%, compared to 24%, and the confirmed objective response was 59%, compared to 13%. For BRAF V600E, the overall response rate (ORR) was 71%, compared to 33%, with a median duration of response of 5.5 months. The overall survival hazard ratio was 0.76.

Safety findings include an incidence of hemorrhage at 16%, compared to 2%, and an incidence of venous thromboembolism at 4%. Cutaneous squamous cell carcinoma (SCC) was observed in 8% of patients, with an increased risk of new cutaneous squamous cell cancers of the skin at 7%. Pyrexia was reported in 5% of patients, with serious non-infectious, febrile drug reactions (grade 3 pyrexia) in 3%. Hyperglycemia incidence was 50%, and alopecia incidence was 22%.