rate was 48.4% (95% CI: 41.6%, 55.2%) in the ZELBORAF 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 ZELBORAF arm and all 12 responses were partial responses (5.5%) in the dacarbazine arm.
Figure 1
Patients Who Received Prior Systemic Therapy
A single-arm, multicenter, multinational trial (Trial 2) was conducted in 132 patients with BRAFV600E mutation-positive metastatic melanoma, as detected by the cobas® 4800 BRAF V600 Mutation Test, who had received at least one prior systemic therapy. The median age was 52 years with 19% of patients being older than 65 years. The majority of patients were male (61%) and Caucasian (99%). Forty-nine percent of patients received ≥ 2 prior therapies. The median duration of follow-up was 6.87 months (range, 0.6 to 11.3).
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 wild-type BRAF melanoma
ZELBORAF has not been studied in patients with wild-type BRAF melanoma.
16 HOW SUPPLIED/STORAGE AND HANDLING
ZELBORAF (vemurafenib) is supplied as 240 mg film-coated tablets with VEM debossed on one side in single bottle of 120 count. The following packaging configuration is available:
NDC 50242-090-01
Storage and Stability: Store at room temperature 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F), See USP Controlled Room Temperature. Store in the original container with the lid tightly closed.
Disposal of unused/expired medicines: The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Use established "collection systems", if available in your location.
17 PATIENT COUNSELING INFORMATION
17.1 Patient Counseling
Patients should be advised of the potential benefits and risks of ZELBORAF. Physicians should instruct their patients to read the Medication Guide before starting ZELBORAF therapy.
BRAFV600E Testing
Inform patients that an assessment of BRAFV600E mutation with the cobas® 4800 BRAF V600 Mutation Test (or other FDA approved test) is required for selection of patients appropriate for ZELBORAF therapy. These patients are the only patients studied and for whom benefit has been shown [see Warnings and Precautions (5.10) and Clinical Studies (14)].
Cutaneous Squamous Cell Carcinoma (cuSCC)
Inform patients that cases of cuSCC have been reported in patients treated with ZELBORAF. Inform patients that their doctor will check their skin regularly during treatment and up to 6 months after treatment. Instruct the patient of the importance of contacting their doctor immediately of any changes in their skin [see Warnings and Precautions (5.1)].
Photosensitivity
Advise patients to avoid sun exposure while taking ZELBORAF. While taking the drug, patients should be advised to wear protective clothing and use a broad spectrum UVA/UVB sunscreen and lip balm (SPF ≥ 30) when outdoors to help protect against sunburn [see Warn
