WASHINGTON (dpa-AFX) - Array BioPharma Inc. (ARRY) said that the National Comprehensive Cancer Network or NCCN has updated the Clinical Practice Guidelines in Oncology for Melanoma to to include BRAFTOVI in combination with MEKTOVI as a Category 1 first-line and second-line treatment option for patients with BRAFV600E or BRAFV600K-mutant metastatic or unresectable melanoma.
A Category 1 recommendation indicates that, based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
The U.S. Food and Drug Administration or FDA approved BRAFTOVI in combination with MEKTOVI on June 27, 2018 for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test based on data from the pivotal Phase 3 COLUMBUS trial, which demonstrated the combination doubled median progression-free survival or mPFS compared to vemurafenib alone.
In the trial, only 5 percent of patients who received BRAFTOVI + MEKTOVI discontinued treatment due to adverse reactions. BRAFTOVI is not indicated for the treatment of patients with wild-type BRAF melanoma.
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