Bavencio® (avelumab)

BL 761049 / BL 761078

Bavencio® (avelumab)

BL 761049 / BL 761078

U.S. License Holder:

EMD Serono Inc.

Date of License:

March-23-2017 / May-09-2017

Last Update:


approved_indications FDA-Approved Indications

BAVENCIO (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for:

Merkel Cell Carcinoma (MCC): Adults and pediatric patients 12 years and older with metastatic MCC;

Urothelial Carcinoma (UC): (I) Maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy; (II) Patients with locally advanced or metastatic UC who: Have disease progression during or following platinum-containing chemotherapy; Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy;

Renal Cell Carcinoma (RCC): First-line treatment, in combination with axitinib, of patients with advanced RCC.

approved_indications U.S. Patent Litigations


Case No(s):

U.S. Patent Nos.
9,402,899 (Immunopotentiative Composition)

Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

EMD Serono, Inc.; Merck KGaA; Pfizer Inc.

Stipulated Dismissal Due to Settlement



Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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