CI = Confidence interval; CR = Complete response; DoR = Duration of response; HR = Hazard ratio; NE = Not estimable; ORR = Overall

response rate; PFS = Progression-free survival; PR = Partial response.

a Estimated with Cox proportional hazard model adjusted by the following stratification factors: American Joint Committee on Cancer (AJCC)

Stage (IIIB, IIIC, IVM1a or IVM1b, versus IVM1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1). b Log-rank test adjusted by the same stratification factors.

Figure 1: Kaplan-Meier Curves for Progression-Free Survival in COLUMBUS

OS was not mature at the time of analysis of PFS.

16 HOW SUPPLIED/STORAGE AND HANDLING

BRAFTOVI (encorafenib) is supplied as 50 mg and 75 mg hard gelatin capsules.50 mg: stylized “A” on orange cap and “LGX 50mg” on beige body, available in cartons

(NDC 70255-020-01) containing two bottles of 60 capsules each (NDC 70255-020-02). 

75 mg: stylized “A” on beige cap and “LGX 75mg” on white body, available in cartons

(NDC 70255-025-01) containing two bottles of 90 capsules each (NDC 70255-025-02).

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see

USP Controlled Room Temperature]. Do not use if safety seal under cap is broken or missing. Dispense in

original bottle. Do not remove desiccant. Protect from moisture. Keep container tightly closed.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Inform patients of the following:

New Primary Cutaneous Malignancies

Advise patients to contact their healthcare provider immediately for change in or development of new skin

lesions [see Warnings and Precautions (5.1)].

 

Hemorrhage

Advise patients to notify their healthcare provider immediately with any symptoms suggestive ofhemorrhage, such as unusual bleeding [see Warnings and Precautions (5.3)].

 

Uveitis

 

Advise patients to contact their healthcare provider if they experience any changes in their vision[see Warnings and Precautions (5.4)].

 

QT Prolongation

 

Advise patients that BRAFTOVI can cause QTc interval prolongation and to inform their physician if they

have any QTc interval prolongation symptoms, such as syncope [see Warnings and Precautions (5.5)].

Females and Males of Reproductive Potential

Embryo-Fetal Toxicity: Advise females with reproductive potential of the potential risk to a fetus. Advisefemales of reproductive potential to use effective non-hormonal contraception during treatment with

BRAFTOVI and for 2 weeks after the final dose. Advise females to contact their healthcare provider if they

become pregnant, or if pregnancy is suspected, during treatment with BRAFTOVI [see Warnings and

 

Precautions (5.6), Use in Specific Populations (8.1)].

 

Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after thefinal dose [see Use in Specific Populations (8.2)].

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility [see Use in SpecificPopulations (8.3)].