Approval Details and Background
Array BioPharma Announces FDA Approval of Braftovi (encorafenib) in Combination with Mektovi (binimetinib) for Unresectable or Metastatic Melanoma with BRAF Mutations
BOULDER, Colo., June 27, 2018 /PRNewswire/ -- Array BioPharma Inc. (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has approved Braftovi capsules in combination with Mektovi tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test. Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma.
Array BioPharma CEO Commentary
"We are thrilled with the approval of Braftovi + Mektovi, which help fill a critical unmet need for patients with advanced BRAF-mutant melanoma, a serious and deadly type of skin cancer," said Ron Squarer, Chief Executive Officer, Array BioPharma. "As presented at ASCO, Braftovi + Mektovi is the first targeted treatment to demonstrate over 30 months median overall survival in a Phase 3 trial. These products represent a new standard of care for BRAF-mutant melanoma patients and we sincerely thank the patients and dedicated researchers who participated in our clinical program."
Availability of Braftovi + Mektovi
Braftovi + Mektovi are now available to order through select specialty pharmacies in the U.S. market.
Physician Commentary
"Despite recent advances, there remains a significant unmet need for treatments that are both effective and well-tolerated for patients with BRAF-mutant melanoma," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. "Now, physicians and patients have the option to consider treatment with Braftovi + Mektovi, which has been shown to delay disease progression, improve overall survival and is generally well-tolerated."
Melanoma Foundation Commentary
"Nearly half of patients diagnosed with metastatic melanoma test positive for the BRAF mutation," said Valerie Guild, Co-Founder and President of the AIM at Melanoma Foundation. "Today's approval is welcome news for the melanoma community as it arms BRAF-mutant late-stage melanoma patients with an important new targeted treatment in their fight against this devastating disease."
Approval Basis: COLUMBUS Trial Efficacy Data
The approval of Braftovi + Mektovi is based on results from the 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 [HR (0.54), (95% CI 0.41-0.71), p<0.0001]). Only 5% of patients who received Braftovi + Mektovi discontinued treatment due to adverse reactions.
Common Adverse Reactions
The most common adverse reactions (≥25%) in patients receiving Braftovi + Mektovi were fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.
COLUMBUS Trial Overall Survival Data
As announced in February 2018, Braftovi + Mektovi reduced the risk of death compared to treatment with vemurafenib 960 mg daily [hazard ratio (HR) of 0.61, [95% CI 0.47, 0.79, p <0.001] in the planned analysis of overall survival (OS) from the COLUMBUS trial. 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. These positive results add to the growing body of clinical evidence supporting the BRAF/MEK inhibitor combination therapy and Array and its partners are working to formally submit these results with global regulatory authorities.
