News from the FDA/CDC

FDA approves avelumab as maintenance for urothelial carcinoma


The Food and Administration has approved a new indication for the PD-L1 inhibitor avelumab.

Physicians can now prescribe avelumab (Bavencio) as maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed after first-line platinum-containing chemotherapy.

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The new indication adds to avelumab use in other patient populations, including people with locally advanced or metastatic UC who experience disease progression during or following platinum-containing chemotherapy. The FDA also previously approved avelumab for patients who experienced UC progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA first approved marketing of avelumab in 2017. Other uses include treatment of metastatic Merkel cell carcinoma and first-line treatment of advanced renal cell carcinoma in combination with axitinib.

The new maintenance therapy indication for avelumab is based on efficacy demonstrated in the JAVELIN Bladder 100 trial. Results from this trial were presented as part of the American Society of Clinical Oncology virtual scientific program.

Investigators randomly assigned 700 patients with unresectable, locally advanced or metastatic UC to intravenous avelumab and best supportive care or best supportive care alone. All participants had UC that had not progressed after first-line platinum-containing chemotherapy.

The median overall survival was 21.4 months in the avelumab arm and 14.3 months in the best supportive care–alone arm (hazard ratio, 0.69; 95% confidence interval, 0.56-0.86). This difference was statistically significant (P = .001).

Avelumab also was associated with significantly longer overall survival in the 51% of participants with PD-L1–positive tumors (hazard ratio, 0.56; 95% confidence interval, 0.40-0.79; P < .001).

Results from the JAVELIN Bladder 100 trial allowed the FDA to convert an initial accelerated approval of avelumab to a regular approval.

Fatigue, musculoskeletal pain, urinary tract infection, and rash were the most common adverse events reported in 20% or more of trial participants. In all, 28% of patients experienced serious adverse events, and one patient died from sepsis during the trial.

Recommended avelumab dosing is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progresses or toxicity becomes unacceptable.

See the full prescribing information for more details.

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