Stage 3 Melanoma Treatment Approved

The US Food and Drug Administration has approved Novartis’ Tafinlar-Mekinist combination for use as a stage 3 melanoma treatment, just four months after the drug was approved for treatment of non-small cell lung cancer with a BRAF V600E mutation.

The BRAF/MEK combination can now be used to treat this particular mutation after studies found that the drug halved patients’ risk of death or melanoma recurrence compared to placebo, in a phase 3 study completed in September.

The primary endpoint in the study was relapse-free survival. There was a 58 percent relapse-free survival rate in the combination arm compared to 39 percent in the placebo group.

Study co-author Axel Hauschild said, “There is no standard of care for adjuvant treatment of stage 3 melanoma, and more effective melanoma treatment options [are needed] for patients at high risk of recurrence following surgical resection.”

Novartis has thanked the FDA for “recognising the scientific advancement Tafinlar and Mekinist may provide in this adjuvant setting.”

Combination use of Tafinlar and Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is now approved in the US, EU, Australia, Canada and other countries.

Click here to read more recent news on melanoma management.



Carroll, J. (October 23, 2017.) FDA adds fresh ‘breakthrough’ for Novartis’ cancer combo Tafinlar and Mekinist. Endpoints News.

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