This article is more than 5 years old. Information may no longer be current.
FDA approves Tafinlar, Mekinist as treatment for metastatic melanoma
Click Here to Manage Email Alerts
The FDA announced today that it has approved Tafinlar (dabrafenib) and Mekinist (trametinib) for treating patients with metastatic or unresectable melanoma.
Tafinlar is a BRAF inhibitor approved to treat patients whose tumors express the BRAF V600E gene mutation, according to an FDA press release. Mekinist is an MEK inhibitor and has been approved to treat patients whose tumors express BRAFV600E or V600K gene mutations. Tafinlar and Mekinist are not approved as combination treatment. Both drugs are marketed by GlaxoSmithKline.
A genetic test called the THxID BRAF Kit (bioMérieux), “a companion diagnostic that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene,” was part of the FDA approval.
Richard Pazdur
“Advancements in our understanding of the biological pathways of a disease have allowed for the development of Tafinlar and Mekinist, the third and fourth drugs the FDA has approved for treating metastatic melanoma in the past two years,” Richard Pazdur, MD, director of the office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
The FDA approved Zelboraf (vemurafenib) and Yervoy (ipilimumab) for treating metastatic or unresectable melanoma in 2011.
The THxID BRAF test approval was based on clinical studies data that supported the Tafinlar and Mekinist approvals, according to the release. Melanoma tissue samples from patients were tested for the mutation.
Two hundred-fifty patients with BRAFV600 gene mutation-positive metastatic or unrespectable melanoma were studied in a Tafinlar trial. Patients randomly received either Tafinlar or dacarbazine. A delay in tumor growth that was 2.4 months later than those receiving dacarbazine was experienced by patients taking Tafinlar.
The most serious side effects reported in patients taking Tafinlar included increased skin cancer risk (cutaneous squamous cell carcinoma), fevers that may be complicated by hypotension, severe rigors, dehydration, kidney failure and increased blood sugar levels. Common side effects reported were hyperkeratosis, headache, fever, joint pain, non-cancerous skin tumors, hair loss and hand-foot syndrome.
Three hundred twenty-two patients with metastatic or unresectable melanoma with the BRAF V600E or V600K gene mutation were included in a Mekinist study. Patients randomly received either Mekinist or chemotherapy, with the Mekinist patients experiencing a tumor growth delay of 3.3 months compared to patients on chemotherapy. Patients did not appear to benefit from Mekinist if they previously had been treated with Tafinlar or other BRAF inhibitors.
Heart failure, lung inflammation, skin infections and vision loss were the most serious side effects reported by patients taking Mekinist. Rash, diarrhea, peripheral edema and skin breakouts resembling acne were common side effects.
The FDA advised women of child-bearing years that both drugs carry the potential to cause fetal harm. Men and women are advised that the drugs have the potential to cause infertility.