Second Indication for Bavencio
May 9, 2017 –The U.S. FDA approved Bavencio® (avelumab - EMD Serono/Pfizer) for a new indication under its accelerated approval program. Bavencio is now indicated to treat patients with locally advanced or metastatic urothelial carcinoma that has progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Urothelial carcinoma accounts for around 90% of bladder cancer cases, affecting nearly 80,000 Americans each year. Once urothelial carcinoma metastasizes, the five-year survival rate is only about 5%.
Bavencio is a programmed death receptor-ligand 1 (PD-L1)-blocking antibody given by intravenous (IV) infusion once every two weeks. It was originally FDA approved on March 23, 2017, to treat Merkel cell carcinoma, which is an aggressive form of skin cancer.
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.