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Locally advanced or metastatic urothelial carcinoma
Mode of Action
PD-L1 blocking antibody (immunotherapy)
FDA approved (USA)
Who is durvalumab for?
Imfinzi (durvalumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
have disease progression during or following platinum-containing chemotherapy
have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy .
Complete information about durvalumab dosage and administration can be found here . The standard dosage is:
10 mg per kilogram of body weight as an intravenous infusion over 60 minutes every 2 weeks
Dilute prior to intravenous infusion.
Consult your doctor for personalised dosage.
What is durvalumab and how does it work?
Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody used to treat adults with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy . Durvalumab is a monoclonal antibody (a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody) — a type of protein that has been designed to recognise and attach to a specific structure, found in certain cells in the body. Durvalumab has been designed to attach to a receptor called PD-1, found on certain cells of the immune system called T cells. Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and, in this way, switch off the T cells. By attaching to the receptor, durvalumab prevents cancer cells from switching off T cells, thereby increasing the ability of the immune system to kill cancer cells .
for locally advanced or metastatic urothelial carcinoma who have disease 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 FDA also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue . The approvals were based on a single-arm clinical trial involving 182 patients. The objective response rate (ORR) was 17.0 % (95 % CI: 11.9, 23.3) across the whole cohort; the ORR for patients with high PD-L1 score (95 patients) was 26.3 % (95 % CI: 17.8, 36.4); the ORR for patients with low or negative PD-L1 score (73 patients) was 4.1 % (95 % CI: 0.9, 11.5). The duration of response ranged between 0.9+ to 19.9+ months (median not reached) . The most common adverse reactions in at least 15 % of patients were fatigue, musculoskeletal pain, constipation, decreased appetite, nausea, peripheral edema, and urinary tract infection. Grade 3 to 4 adverse events were seen in 43 % of patients. Infection and immune-related adverse events such as pneumonitis, hepatitis, colitis, thyroid disease, adrenal insufficiency, and diabetes were also seen with durvalumab .
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