FDA Approves Combination Drug Therapy for Advanced Melanoma
The FDA recently approved a new drug combination to treat melanoma cases that can’t be removed by surgery or are late-stage. The drugs Mekinist (trametinib) and Tafinlar (dabrafenib) will block the molecular pathway that promotes cancer cell growth, providing treatment for patients with the specific gene mutation involved in melanoma tumors. “This approval illustrates the value of continuing to study drugs in combination for clinical development,” Richard Pazdur, M.D., director of the Office of Hermatology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, commented on the significance of this new development.
Research compared 162 participants who were either given Mekinist and Tafinlar or only Tafinlar. Seventy-six percent of participants treated with Mekinist and Tafinlar had their cancer shrink or disappear, lasting an average of 10.5 months. Improvement had much lower rates for those treated with only Tafinlar, with 54% objective responses lasting an average of 5.6 months.
Side effects for the combination of drugs included fever, chills, tiredness, rash, nausea, vomiting, diarrhea, abdominal pain, peripheral edema, cough, headache, joint pain, night sweats, decreased appetite, constipation, and muscle pain. More serious side effects included bleeding, clot formation, heart failure, skin and eye problems, and the risk of birth defects and infertility. However, the overall side effects were actually reduced when the drugs were used in combination.
This combination therapy was given accelerated approval based on the research proving its benefit to patients. This will allow the treatment to be available to patients while it is still undergoing clinical trials. According to the FDA news release, the drug combination “demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.” This is an important option for healthcare providers who are treating melanoma patients, but should be approached cautiously as there are numerous side effects and it is still being tested.