Imfinzi (durvalumab)

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Imfinzi (durvalumab)

Manufacturer AstraZeneca
Disease Bladder Cancer
Indication Locally advanced or metastatic urothelial carcinoma
Mode of Action PD-L1 blocking antibody (immunotherapy)
Approval Status FDA approved (USA)
Strength 50 mg/mL

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 [1].

Recommended dose

Complete information about durvalumab dosage and administration can be found here [1].
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 [2].
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 [1].

What is deutetrabenazine's approval status?

Imfinzi (durvalumab) was approved by:
  • FDA (USA) on May 1, 2017 [2]
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 [2].
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) [1][2].
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 [1][2].
References
[1] Summary of Product Characteristics [FDA]: Imfinzi (durvalumab), AstraZeneca, Apr. 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761069s000lbl.pdf
[2] FDA.gov: Approved drugs. Durvalumab (Imfinzi). (last update 01/05/2017), cited on: 27/09/2017.
https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm555930.htm

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.








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