3 New Immunotherapy Approvals for Bladder and Urinary Tract Cancer

During May, the American Food and Drug Administration FDA approved 3 immunotherapy drugs for bladder and urinary tract cancer: PD-L1 inhibitors durvalumab (Imfizni) and avelumab (Bevancio), and PD-1 inhibitor pembrolizumab (Keytruda).

All three immunotherapy drugs were approved for treating regionally advanced (locally advanced) or stage 4 (metastatic ) bladder and urinary tract cancer (urothelial carcinoma). With these approvals, all immune checkpoint inhibitor immunotherapies except ipilimumab have received FDA approval for bladder and urinary tract cancer treatment.

Scope of Approval

These three immunotherapies (durvalumab, avelumab and pembrolizumab) were approved for patients with regionally advanced or stage 4 cancer progressing during or after platinum-containing chemotherapy, the standard treatment for bladder and urinary tract cancer.

Although patients with higher tumor PD-L1 expression respond better to immunotherapy, approvals were granted regardless of whether PD-L1 was positive or negative.

Recommended Dose

• Durvalumab: 10 mg/kg, intravenously over 60 minutes, every two weeks
• Avelumab: 10 mg/kg, intravenously over 60 minutes, every two weeks
• Pembrolizumab: 200 mg, intravenously over 60 minutes, every three weeks

Side effects of these drugs are considered within the general immunotherapy side effects framework.

Although these new immunotherapy treatments received approval from the American Food and Drug Administration FDA, the pioneering agency followed worldwide for new drug approvals, they are not yet reimbursed in our country. We will announce on our website if they enter reimbursement coverage.