Cancer Treatment Today

Tafinlar is only indicated for unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA approved test. On January 13, 2018Tafinlar had been given FDA breakthrough therapy designation for lung cancer, meaning the drug will be fast-tracked within the U.S. regulatory system. At this point, it remains only approved BRAF + melanoma.

The designation was based on an abstract was presented at 2013 ASCO, with 17 patient. Dabrafenib showed early antitumor activity in BRAF V600E mutationpositive pretreated NSCLC pts, with an ORR of 54% and with the longest duration of response of 49 weeks thus far. Dabrafenib is generally well tolerated, and the study has met the minimum response rate ( 3 of first 20 pts) to continue into the second stage. This study represents the first clinical evidence of BRAF as a therapeutic target in NSCLC.

Results in different solid tumors types have been mixed, with emerging positive data in NSCLC. Results from a basket study looking at BRAFV600E in non-melanoma showed that among 19 patients with NSCLC 42% had objective response with 14 patients having a reduction in tumor size. Similarly, a retrospective study of vemurafenib treatment in patients with BRAF-mutant NSCLC showed patients with V600E mutations had a 54% disease response rate.

1. Gautschi O, Milia J, Cabarrou B, et al. Targeted therapy for patients with BRAF-mutant lung cancer results from the European EURAF cohort. J Thorac Oncol. 2015;10:1451-1457.
2. Planchard D, Kim TM, Mazieres J, et al. Dabrafenib in patients with BRAFV600E-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016;17:642-650.
3. Planchard D, Besse B, Groen HJM, 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 Oncol. 2016;17:984-993.

Taflinar, Prescribing Information, 2013