FDA approves Mekinist in combination with Tafinlar to treat patients with advanced melanoma

NEW YORK — The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week. 

Both Mekinist and Tafinlar are only available in limited distribution, and Onco360 is one of the few pharmacies with access to both medications.

Mekinist and Tafinlar are used to block signaling in different sites of the same molecular pathway that promotes cancer cell growth. They are specifically indicated as a combination therapy for patients with melanoma whose tumors express gene mutations called BRAF V600E and V600K1. Clinical trial results for the combination therapy were highly encouraging.

Results showed that 76% of participants treated with Mekinist in combination with Tafinlar had their cancer shrink or disappear (objective response) that lasted an average of 10.5 months. In contrast, 54% of participants treated with Tafinlar as a single agent experienced objective responses that lasted an average of 5.6 months. 

Clinical trials are ongoing to determine whether Mekinist in combination with Tafinlar improves survival.