Mekinist and Tafinlar Combination Approved to Treat Lung Cancer
June 23, 2017 – The U.S. FDA has approved Mekinist® (trametinib) and Tafinlar® (dabrafenib), manufactured by GlaxoSmithKline, as a combination therapy to treat patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. The combination was previously approved for the treatment of advanced melanoma that has metastasized or cannot be surgically removed, and that has been tested as positive for specific genetic mutations (BRAF V600E or BRAF V600K). Mekinist and Tafinlar are oral kinase inhibitors; Mekinist inhibits MEK, and Tafinlar inhibits BRAF.
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.