A combination melanoma treatment approved by FDA is now available through select specialty pharmacies.
Braftovi capsules in combination with Mektovi tablets (Array BioPharma) was approved for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.
The combination treatment is the first targeted treatment to demonstrate over 30 months median overall survival in a phase 3 trial, said Ron Squarer, CEO of Array BioPharma, in a statement from the company.
Braftovi + Mektovi will “help fill a critical unmet need for patients with advanced BRAF-mutant melanoma, a serious and deadly type of skin cancer,” Squarer said.
Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma.
"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, in the Array statement. "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."
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). Five percent of patients who received the combination medicine discontinued treatment due to adverse reactions.