The US Food and Drug Administration (FDA) has approved the Bavencio (avelumab) injection developed by Merck and Pfizer to treat patients with locally advanced or metastatic urothelial carcinoma (UC).
Following this approval, the drug can be used on UC patients who have exhibited progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
The drug will be co-commercialised by EMD Serono, the biopharmaceutical business of Merck in the US and Canada, and Pfizer.
EMD Serono research and development global head Luciano Rossetti said: “This approval for Bavencio in patients with locally advanced or metastatic urothelial carcinoma exemplifies our unwavering commitment to finding new treatments for the most challenging cancers.”
FDA previously granted Bavencio accelerated approval for the treatment of adults and pediatric patients older than 12 with metastatic Merkel cell carcinoma (MCC).
Pfizer oncology global president Liz Barrett said: “This approval builds on the ongoing clinical development programme for Bavencio in urothelial carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers.
“By drawing on the strength of the alliance, as well as Pfizer’s deep experience in genitourinary cancers, we believe Bavencio will be an important treatment option, and we hope it will help to improve outcomes for these patients.”
Both companies conducted JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicentre study to determine the efficacy and safety of Bavencioto treat various solid tumours.
The study included 242 patients and will be presented at an upcoming medical congress.
Bavencio is a human programmed death ligand-1 (PD-L1) blocking antibody designed to potentially engage both the adaptive and innate immune systems.
By binding to PD-L1, Bavencio is thought to prevent tumour cells from using PD-L1 for protection against white blood cells (such as T-cells) thereby exposing them to anti-tumour responses.
About 90% of urothelial carcinomas are reported to be bladder cancer, which is also the sixth most common cancer in the US.