FDA批准阿维鲁单抗(Avelumab)用于转移性默克尔细胞癌、晚期或转移性尿路上皮癌以及与阿西替尼联合用于晚期肾细胞癌的治疗

Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody jointly developed by Pfizer and Merck of Germany. It was first approved by the FDA on March 23, 2017. Avelumab targets the PD-1/PD-L1 pathway (proteins found on human immune cells and some cancer cells). By blocking these interactions, avelumab helps the body's immune system attack cancer cells.

Avelumab’s approved indications

1. Metastatic Merkel cell carcinoma

On March 23, 2017, the U.S. Food and Drug Administration (FDA) accelerated approval of Avelumab for the treatment of adults and children 12 years and older with metastatic Merkel cell carcinoma (MCC), including patients who have not received chemotherapy in the past. It is the first FDA-approved treatment for metastatic MCC, a rare and aggressive form of skin cancer.

2. Urothelial carcinoma

On May 9, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

3. Patients with advanced renal cell carcinoma

On May 14, 2019, the U.S. Food and Drug Administration (FDA) approved the combination of avelumab and axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first time the FDA has approved an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC.

4. Locally advanced or metastatic urothelial cancer

On June 30, 2020, the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Avelumab for the maintenance treatment of patients with locally advanced or metastatic urothelial cancer who have not progressed on first-line platinum-containing chemotherapy (UC).

About Avelumab

Avelumab is a human anti-programmed death ligand 1 (PD-L1) antibody. Avelumab has been shown to exert both adaptive and innate immune functions in preclinical models. By blocking the interaction of PD-L1 with the PD-1 receptor, avelumab has been shown to unleash inhibition of T cell-mediated anti-tumor immune responses in preclinical models.