Array BioPharma announced that the National Comprehensive Cancer Network (NCCN) has updated the Clinical Practice Guidelines in Oncology for Melanoma 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.
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The U.S. Food and Drug Administration (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 (mPFS) compared to vemurafenib alone (14.9 months versus 7.3 months, respectively [hazard ratio (HR) (0.54), (95% CI 0.41-0.71), p <0.0001]. In the trial, only 5% 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.
"We greatly appreciate the NCCN's rapid evaluation and recommendation for BRAFTOVI + MEKTOVI as a Category 1 treatment option for patients with advanced BRAF-mutant melanoma," said Ron Squarer, Chief Executive Officer. "These products represent a new standard of care for patients with this deadly type of skin cancer."
A Category 1 recommendation indicates that, based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
In June 2018, Array also announced updated results from the COLUMBUS trial which demonstrated that the combination encorafenib and binimetinib reduced the risk of death compared to treatment with vemurafenib [HR (0.61), (95% CI 0.47-0.79, p <0.0001] in the planned analysis of overall survival (OS). Median OS was 33.6 months for patients treated with the combination, compared to 16.9 months for patients treated with vemurafenib as a monotherapy.