Generic Name: dabrafenib

Pronunciation: N/A

Abbreviation: N/A

Other Market Name: N/A

Drug Class: Targeted Therapy Medications

Company: Novartis

Approval Status: Approved

Generic Version Available: No

Experimental Code: N/A

Drug Indication

Tafinlar is a kinase inhibitor approved to treat certain cancers with BRAF V600 mutations. It can be used alone to treat people with inoperable or metastatic melanoma. It is approved in combination with the companion drug Mekinist for treatment of inoperable or metastatic melanoma and for prevention of melanoma recurrence after surgery. The combination is also approved for metastatic non-small-cell lung cancer (NSCLC) and advanced thyroid cancer.

General Info

Tafinlar is a targeted therapy that acts against certain mutated BRAF kinase proteins, which play a role in cell growth. Certain BRAF gene mutations, including V600E, promote tumor growth. It is more effective when combined with the MEK inhibitor Mekinist.

Clinical trials showed that Tafinlar alone delayed progression of melanoma in people with BRAF V600E mutations. The combination of Tafinlar plus Mekinist improved survival and delayed cancer recurrence in those with V600E or V600K mutations. Other studies showed that Tafinlar plus Mekinist shrank tumors in about 60% of people with metastatic NSCLC or anaplastic thyroid cancer with BRAF V600E mutations. Tafinlar was first approved in 2013.


Dosing Info:

Tafinlar is a twice-daily pill that should be taken at least one hour before or two hours after a meal.

Side Effects

Common side effects of Tafinlar, alone or with Mekinist, include fever, fatigue, nausea, vomiting, diarrhea, skin rash, hand-foot syndrome (palmar-plantar erythrodysesthesia), hair loss, muscle and joint pain and swelling. More serious adverse events may include new malignancies, heavy bleeding, gastrointestinal inflammation, heart and eye problems, severe skin reactions, high fever and elevated blood glucose. Tafinlar may promote growth of tumors that do not carry the targeted BRAF mutations. It can cause fetal harm if used during pregnancy.

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Last Reviewed: October 23, 2019