Kisqali/Femara Combination Package Approved
May 4, 2017 – The U.S. Food and Drug Administration (FDA) has approved Kisqali/Femara, as a combination package. The new combination includes Novartis drugs, Kisqali® (ribociclib) and Femara® (letrozole). Kisqali was granted initial FDA approval in March 2017 to be used as a first-line treatment for postmenopausal women who have metastatic or advanced hormone receptor positive (HR2+) human epidermal growth factor receptor-2 negative (HER2-) breast cancer. Kisqali is indicated for use along with any aromatase inhibitor, such as anastrozole, exemestane or letrozole.
The co-packs will be available in three strengths and is due to launch later in May. The new combination product, will be priced equal to the cost of Kisqali alone, and will contain a one-month supply of both Kisqali and Femara (an aromatase inhibitor).
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 1800-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.