EMA Grants Trametinib Accelerated Review for Metastatic Melanoma

The European Medicines Agency has granted an accelerated review process for GSK’s trametinib, a MEK inhibitor, for treatment of metastatic melanoma. GSK has filedresults from the monotherapy phase III METRIC trial as well as phase I/II trial results of the combination of trametinib plus dabrafenib, a BRAF inhibitor. Phase III combination trials of trametinib plus dabrafenib both versus the current approved BRAF inhibitor, vemurafenib, and against dabrafenib alone are in progress.

Addition of elesclomol to paclitaxel does not improve PFS in advanced melanoma patients, phase III trial shows

Results of the phase III SYMMETRY trial in stage IV metastatic melanoma patients don’t show an improvement in PFS when elesclomol was added to paclitaxel chemotherapy. But, patients with normal LDH levels did have a statistically significant improvement in median PFS for the combination therapy.