Braftovi and Mektovi Approved to Treat Melanoma
June 27, 2018 – The U.S. FDA has approved Braftovi™ (encorafenib) and Mektovi® (binimetinib), both manufactured by Array BioPharma, to be used in combination to treat unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutations.
Both drugs are kinase inhibitors, and in clinical studies doubled median progression-free survival (PFS) time versus vemurafenib. Patients who received Braftovi and Mektovi had a median PFS time of 14.9 months compared to 7.3 months with vemurafenib. During the study, just 5% of patients discontinued Braftovi and Mektovi due to adverse reactions. The combination also reduced the risk of death and improved overall survival time – 33.6 months as opposed to 16.9 months with vemurafenib.
Approximately half of all patients diagnosed with melanoma have the BRAF gene mutation. An estimated 10,000 people die of melanoma each year in the United States, and 74,000 new cases are diagnosed annually. Braftovi and Mektovi work by targeting key enzymes involved in the development of melanoma.
Recommended dosing with the combination is 450mg of Braftovi once daily, and 45mg of Mektovi twice per day. Braftovi is available in 50mg and 75mg capsules. Mektovi comes in 15mg tablets.
Array BioPharma has launched both medications at an average wholesale price (AWP) of $13,172.40 per month.
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.