Updated Approval for Tafinlar and Mekinist
November 20, 2015 – The U.S. Food and Drug Administration (FDA) approved Mekinist (trametinib) and Tafinlar (dabrafenib) as combination therapy to treat patients with advanced melanoma that has metastasized or that cannot be surgically removed, and that has been tested as positive for specific genetic mutations – BRAF V600E or BRAF V600K. Tafinlar and Mekinist are manufactured by for GlaxoSmithKline. Mekinist and Tafinlar are oral kinase inhibitors; Mekinist inhibits MEK and Tafinlar inhibits BRAF. In January 2014, Mekinist and Taflinar originally received accelerated approval and this new regular approval was based on two, Phase III studies that confirmed the combination improved overall survival and progression-free survival compared to Tafinlar alone. In the COMBId trial, treatment with Mekinist plus Tafinlar improved overall survival by 6.4 months compared to Tafinlar alone (25.1 months versus 18.7 months). In the COMBIv trial, the combination improved progression-free survival by 4.1 months compared to Tafinlar alone (11.4 months versus 7.3 months).
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.