Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E Mutation

“On May 29, 2013, dabrafenib (Tafinlar) was approved for treatment of patients with unresectable or metastatic melanoma withBRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Concurrent with this approval, FDA approved the THxID BRAF assay (bioMérieux, Inc) for detection of BRAF V600E mutations. Dabrafenib is not indicated for the treatment of patients with wild-type BRAF melanoma, due to the potential risk of tumor promotion.”

FDA Asked to Approve New Combination Treatment for Melanoma

Two new drugs that target melanomas were approved by the US Food and Drug Administration in May, and the drug developer has already filed for approval to use them in combination. The drugs are dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), a MEK inhibitor, and both are made by GlaxoSmithKline. The combination treatment request is based on promising results of a Phase I/II trial, which showed that the two drugs work better together than dabrafenib does alone. Results of a Phase III trial of the combination therapy are expected later this year.

Cancer Drug Targeting BRAF Gene May Be Effective in Lung Cancer

A small subset of patients with non-small cell lung cancer (NSCLC), especially those with lung adenocarcinoma, have a mutation in the BRAF gene called V600E. An ongoing phase II clinical trial is investigating whether the BRAF inhibitor dabrafenib (Tafinlar) benefits patients with this mutation. Tafinlar is currently approved for treatment of the skin cancer melanoma. Recently released trial results show that the drug partially shrank tumors in 40% of advanced NSCLC patients whose cancer had worsened after at least one round of chemotherapy. Another 20% of study participants maintained stable disease (tumors neither shrinking nor growing). Almost half of the patients currently remain on the treatment. These findings are the first evidence that treatments targeting the BRAF V600E mutation may be effective in lung cancer.

FDA Greenlights Two New Targeted Treatments for Melanoma

Good news for people with melanomas that have spread—the U.S. Food and Drug Administration just approved two new drugs that target tumors with common mutations. The drugs are dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), an MEK inhibitor. Developed by the pharmaceutical firm GlaxoSmithKline, both drugs target BRAF V600E mutations, which occur in about half of melanoma tumors. In addition, trametinib also targets V600K mutations, which are the next most common BRAF abnormalities. While these drugs have been tested in combination, using them together is not yet approved. The FDA also okayed a new test for the BRAF V600E mutation that is made by diagnostics firm bioMerieux.

2 Skin Cancer Drugs Win FDA Approval

“Two new drugs for metastatic or inoperable melanoma, dabrafenib (Tafinlar) and trametinib (Mekinist), were approved by the FDA on Wednesday.The agency also approved a companion diagnostic test for both agents to detect certain mutations in the BRAF gene that render melanoma cells susceptible to the drugs.”