FDA approval was based on results from an open-label clinical trial of patients with various rare, BRAF V600E–positive cancers. In a group of 23 patients, 57% experienced a partial response and 4% experienced a full response. In the response group, nine patients had no significant tumor growth for a period of at least 6 months.
The most common side effects of dabrafenib/trametinib are fever, rash, chills, headache, joint pain, cough, fatigue, nausea, vomiting, diarrhea, myalgia, dry skin, decreased appetite, edema, hemorrhage, high blood pressure, and difficulty breathing. Both drugs can cause damage to developing fetuses, and women should be advised to use proper contraception.
“This approval demonstrates that targeting the same molecular pathway in diverse diseases is an effective way to expedite the development of treatments that may help more patients,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in the press release.
Find the full press release on the FDA.