Chugai files NDA for vemurafenib for melanoma

Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss drug major Roche (ROG: SIX), has filed a new drug application to the Ministry of Health, Labor and Welfare (MHLW) for oral, selective BRAF kinase inhibitor vemurafenib for the treatment of melanoma with BRAFV600 mutation.

Chugai filed the application with the MHLW based on the results from global Phase III clinical trial, the BRIM3 study, and the Japanese Phase I/II clinical trial (The JO28178 study). The BRIM3 study compared vemurafenib to dacarbazine, a standard of care, in 675 patients with previously chemotherapy naive metastatic melanoma with BRAFV600 mutation, diagnosis by cobas 4800 BRAF V600 Mutation Test. As a result, the risk of death was reduced by 63% for people who received vemurafenib compared to those who received dacarbazine. Patients who received vemurafenib had a 74% reduced risk of the disease getting worse or dying compared to those who received dacarbazin. Median PFS was 5.3 months for those who received vemurafenib compared to 1.6 months for those who received dacarbazine.

The JO28178 study was conducted in two phases in 11 patients of melanoma with BRAFV600 mutation, diagnosis by cobas 4800 BRAF V600 Mutation Test. The Phase I portion was conducted to evaluate initial safety, and the Phase II portion was conducted to evaluate the efficacy and safety. The result showed that the efficacy and the tolerability of vemurafenib in Japanese patients with melanoma are confirmed.