On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio®) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

FDA Approves Avelumab for Urothelial Carcinoma Maintenance Treatment

Efficacy was investigated in a randomized (1:1), multicenter, open-label trial (JAVELIN Bladder 100; NCT02603432) that enrolled 700 patients with unresectable, locally advanced or metastatic UC that had not progressed with four to six cycles of first-line platinum-containing chemotherapy. Patients were randomized to receive either avelumab via IV every two weeks plus best supportive care (BSC) or BSC alone. Treatment was initiated 4–10 weeks after the last chemotherapy dose.

The main efficacy outcome measure was overall survival (OS) in all patients and in patients with PD-L1-positive tumors. Median OS in all patients was 21.4 months in the avelumab arm and 14.3 months in the BSC-alone arm (HR = 0.69; 95%CI = 0.56, 0.86; p = 0.001). Among patients with PD-L1-positive tumors (51%), OS hazard ratio was 0.56 (95% CI = 0.40, 0.79; p < 0.001). In an exploratory analysis of patients with PD- L1- negative tumors (39%), OS hazard ratio was 0.85 (95% CI = 0.62, 1.18).

The most common adverse reactions (> 20%) were fatigue, musculoskeletal pain, urinary tract infection, and rash. One patient died from sepsis, and 28% of patients had serious adverse reactions.

The recommended avelumab dose is 800 mg via IV infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.

Results from the study supported the conversion of accelerated approval of avelumab to a regular approval.

View full prescribing information for avelumab.

The review used the Real Time Oncology Review, which streamlined data submission prior to filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate FDA’s assessment. FDA approved the application three months prior to its goal date.

FDA granted avelumab priority review and breakthrough therapy designations. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.  

For assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.