MEKINIST is indicated, in combination with dabrafenib, for...the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Thyroid Carcinoma...Useful in certain circumstances, bullet added: Dabrafenib/trametinib for patients with BRAF V600E mutation that has progressed following prior treatment with no satisfactory alternative treatment options.

Patients with BRAF V600E-positive malignancies should be treated with the BRAF inhibitor dabrafenib (150 mg twice daily) plus the MEK inhibitor trametinib (2 mg once daily) if they are available [V, B]

...- positive anaplastic thyroid cancer, determined by immunohistochemistry for the presence of the BRAF V600E mutation in tumor tissue, genetic/molecular testing of the tumor, or by liquid biopsy of circulating DNA to determine the presence of the BRAF V600E mutation (if the histological examination is...

Here we present final efficacy and safety results of a phase 2 basket trial of dabrafenib (BRAF kinase inhibitor) plus trametinib (MEK inhibitor) in eight cohorts of patients with BRAFV600E-mutated advanced rare cancers: anaplastic thyroid carcinoma (n = 36), biliary tract cancer (n = 43), gastrointestinal stromal tumor (n = 1), adenocarcinoma of the small intestine (n = 3), low-grade glioma (n = 13), high-grade glioma (n = 45), hairy cell leukemia (n = 55) and multiple myeloma (n = 19)...The primary endpoint of investigator-assessed overall response rate in these cohorts was 56%, 53%...The encouraging tumor-agnostic activity of dabrafenib plus trametinib suggests that this could be a promising treatment approach for some patients with BRAFV600E-mutated advanced rare cancers.

We report an updated analysis describing the efficacy and safety of dabrafenib plus trametinib in the full ROAR ATC cohort of 36 patients....The investigator-assessed ORR was 56% (95% confidence interval, 38.1%-72.1%), including 3 complete responses; the 12-month DOR rate was 50%. Median PFS and OS were 6.7 and 14.5 months, respectively. Respective 12-month PFS and OS rates were 43.2% and 51.7%, and the 24-month OS rate was 31.5%....These updated results confirm the substantial clinical benefit and manageable toxicity of dabrafenib plus trametinib in BRAF V600E–mutant ATC.

BRAF V600E patients were treated with dabrafenib 300 mg per day and trametinib 2 mg per day (combo regimen)...Best response in BRAF V600E was 4 partial response (PR), 3 stable disease (SD) and response in 1 patient has not been assessed yet. Combo was well tolerated...

Dabrafenib plus trametinib is the first regimen demonstrated to have robust clinical activity in BRAF V600E-mutated anaplastic thyroid cancer and was well tolerated.

...targeted therapy was initiated against the BRAF V600E mutation with oral dabrafenib at 150 mg twice daily and trametinib at 2 mg daily. After beginning treatment, the patient sustained a marked clinical improvement and healing of the fistula. Follow-up CT imaging after 2 months of therapy showed a radiologic response of the lung nodules.

We herein report the rechallenge of a 52-year-old ATC patient with BRAF V600E mutation with dabrafenib plus trametinib. She presented with recurrent and progressive disease despite surgery, radiation therapy, 3 different chemotherapy regimens, and combination of dabrafenib-trametinib in different settings. She was rechallenged with dabrafenib-trametinib, and had a good response.