Dosage of Encorafenib

1. Patient Selection

Unresectable or Metastatic Melanoma with Positive BRAF V600E or V600K Mutation: Confirm the presence of BRAF V600E or V600K mutation in tumor specimens before initiating encorafenib treatment.

Metastatic Colorectal Cancer with Positive BRAF V600E Mutation: Confirm the presence of BRAF V600E mutation in plasma or tumor tissue before initiating encorafenib treatment. If no mutation is detected in plasma specimens, test tumor tissue.

Metastatic Non-Small Cell Lung Cancer with Positive BRAF V600E Mutation: Confirm the presence of BRAF V600E mutation in tumor or plasma specimens before initiating encorafenib treatment. If no mutation is detected in plasma specimens, test tumor tissue.

2. Recommended Dosage for Unresectable or Metastatic Melanoma (BRAF V600E/V600K Mutation-Positive) and Metastatic Non-Small Cell Lung Cancer (BRAF V600E Mutation-Positive)

The recommended dosage of encorafenib is 450 mg (six 75 mg capsules) orally once daily, administered in combination with binimetinib, until disease progression or unacceptable toxicity occurs. Refer to the binimetinib prescribing information for recommended binimetinib dosage details.

3. Recommended Dosage for Metastatic Colorectal Cancer (BRAF V600E Mutation-Positive)

The recommended dosage of encorafenib is 300 mg (four 75 mg capsules) orally once daily. It is administered in combination with either:

Cetuximab (given every two weeks) plus the mFOLFOX6 regimen; or

Cetuximab (given weekly),

until disease progression or unacceptable toxicity occurs.

4. Administration

Encorafenib may be taken with or without food. Do not make up for a missed dose within 12 hours before the next scheduled encorafenib dose. If vomiting occurs after taking encorafenib, do not take an extra dose; instead, continue with the next scheduled dose as planned.

FDA，2025.03