Tafinlar and Mekinist Approved to Treat Thyroid Cancer
May 4, 2018 – The U.S. FDA has approved Tafinlar® (dabrafenib) and Mekinist® (trametinib), manufactured by Novartis, to be used jointly to treat certain patients with anaplastic thyroid cancer (ATC). Candidates must have BRAF V600E mutation-positive ACT that cannot be surgically removed or has spread (metastasized) to other parts of the body.
At present, the combination is the first and only FDA-approved treatment for this particular patient population. ATC often spreads rapidly and is resistant to most anti-cancer treatments. Patients diagnosed with the disease face a poor prognosis due to its aggressive nature. Typically, it occurs in individuals over 60 years of age, and accounts for approximately 2% of all thyroid cancers diagnosed in the United States.
Tafinlar and Mekinist both carry individual approvals to treat other forms of BRAF V600-positive metastatic cancer. The combination was also approved on April 30, 2018, for joint use to treat BRAF V600-positive metastatic melanoma.
According to the FDA, the new ATC approval for the two drugs demonstrates the importance of targeting specific molecular pathways found in multiple diseases. This type of research can offer the chance to develop treatment options that benefit a large number of patients spread across several disease states.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.