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Therapeutic efficacy of Vemurafenib

Treatment-Naïve Patients with BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma

The confirmed, investigator-assessed best overall response rate was 48.4% (95% CI: 41.6%, 55.2%) in the  Vemurafenib arm compared to 5.5% (95% CI: 2.8%, 9.3%) in the dacarbazine arm. There were 2 complete responses (0.9%) and 104 partial responses (47.4%) in the Vemurafenib arm and all 12 responses were partial  responses (5.5%) in the dacarbazine arm.

Patients with BRAF V600E Mutation-Positive Metastatic Melanoma Who Received Prior Systemic Therapy

The confirmed best overall response rate as assessed by an independent review committee (IRC) was 52%  (95% CI: 43%, 61%). There were 3 complete responses (2.3%) and 66 partial responses (50.0%). The median time to response was 1.4 months with 75% of responses occurring by month 1.6 of treatment. The median  duration of response by IRC was 6.5 months (95% CI: 5.6, not reached).

Patients with BRAF V600E Mutation-Positive Melanoma with Brain Metastases

Patients with Wild-Type BRAF Melanoma 

Vemurafenib has not been studied in patients with wild-type BRAF melanoma.

Patients with Erdheim-Chester Disease (ECD)

The efficacy of  Vemurafenib in ECD was based on best overall response rate maintained on two occasions at  least four weeks apart, as assessed by the investigator using RECIST v 1.1. The median duration of follow up was 26.6 months in ECD patients (range, 3.0 to 44.3 months). The median time to response was 11 months (95% CI: 3.7, 14.6). The median DOR was not estimable.

from FDA，2020.12