Bavencio Approved for Merkel Cell Carcinoma
March 23, 2017 – The U.S. FDA approved Bavencio® (avelumab) for the treatment of adult and pediatric patients 12 years of age and older with metastatic Merkel cell carcinoma (mMCC). Bavencio, manufactured by EMD Serono and Pfizer, is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody. FDA approval was based on a Phase II trial in patients with mMCC that demonstrated that 33 percent of patients treated with Bavencio had complete or partial shrinkage of their tumors. EMD Serono and Pfizer are conducting confirmatory studies to verify that the drug provides a clinical benefit in these patients. Recommended dosing is 10mg/kg as an intravenous (IV) infusion every 2 weeks. Bavencio was launched upon approval. It is available through a limited network of specialty pharmacies.
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.