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02-05-2018 | Oncology | Main feed | News

approvalsWatch

Adjuvant dabrafenib–trametinib approved for mutated melanoma

medwireNews: US patients with lymph node-positive melanoma harboring the BRAF V600E or V600K mutations may now be treated with adjuvant dabrafenib and trametinib.

The FDA approval is based on findings from the COMBI-AD trial demonstrating a significant improvement in the relapse-free survival of patients with stage III BRAF-mutated melanoma with the combination treatment versus placebo.

The decision follows earlier approval of the BRAF inhibitor dabrafenib in combination with the MEK inhibitor trametinib in patients with unresectable or metastatic BRAF-mutated melanoma, and also for the treatment of metastatic non-small-cell lung cancer with a BRAF V600E mutation.

The recommended adjuvant treatment dosage for melanoma is dabrafenib 150 mg twice daily plus trametinib 2 mg once daily for up to a year, or until disease recurrence or unacceptable toxicity.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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