FDA Approves New Targeted Therapy Drug Combination for Lung Cancer

The US Food and Drug Administration (FDA) has approved the targeted therapy drugs Tafinlar (dabrafenib) and Mekinist (trametinib) to be used together to treat people with a specific type of non-small cell lung cancer that has spread in the body (metastasized). These are the first FDA drug approvals for a type of lung cancer with a BRAF V600E gene mutation. Cells with changes in the BRAF gene make an altered protein that helps them grow. Tafinlar and Mekinist target this protein and related proteins.

The FDA also approved a genetic test that can detect several different mutations, including EGFR, ROS1, and BRAF, in a single test from one tissue sample. Test results could be used to help select drugs and drug combinations for people with mutation-related lung cancers.

Tafinlar and Mekinist had already been approved to treat people with BRAF-mutated advanced melanoma skin cancer. The FDA based the new approvals on a clinical trial of 171 people with BRAF V600E mutation-positive non-small cell lung cancer that had metastasized.

Ninety-three people in the study received the combination treatment. Part of that group had previously been treated with chemotherapy and part had not. Of those who had received chemo, 63% had a response, meaning their tumors shrank, and the improvement lasted for an average of 12.6 months. Those who’d had no previous treatment had an overall response rate of 61%. The average duration of the response could not be calculated, but for most people in that group the improvement lasted longer than 6 months.

The other 78 people in the trial had previously been treated with chemotherapy and received Tafinlar alone. Their overall response rate was 27%, and the improvement lasted for an average of 9.9 months.

The FDA approved the drugs using breakthrough therapy designation, one way to speed up evaluation of drugs to treat serious conditions. The drugs were also granted orphan product designation, which provides incentives to the drug’s developer because they are intended to treat a rare disease.

The drugs are taken as pills or capsules. The most common side effects include dry skin, rash, itching, sensitivity to the sun, headache, fever, joint pain, fatigue, hair loss, nausea, and diarrhea.

Less common but serious side effects can include bleeding, heart rhythm problems, liver or kidney problems, lung problems, severe allergic reactions, severe skin or eye problems, and increased blood sugar levels.

Some people treated with these drugs develop skin cancers, especially squamous cell skin cancers. It’s important for people taking these drugs to let their doctors know right away if they notice any new growths or abnormal areas on their skin.

The American Cancer Society medical and editorial content team

Our team is made up of doctors and oncology certified nurses with deep knowledge of cancer care as well as journalists, editors, and translators with extensive experience in medical writing.


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