What is Bavencio (avelumab) for?
Bavencio (avelumab) is an immunotherapy (a programmed death ligand-1 (PD-L1) blocking antibody) indicated for the treatment of people with metastatic Merkel cell carcinoma (MCC)1,3,6 (a rare type of skin cancer) and adult patients with locally advanced or metastatic urothelial carcinoma1 (cancer of the bladder and urinary system).
How does Bavencio (avelumab) work?
Bavencio (avelumab) targets the PD-1/PD-L1 pathway2 which is involved in the regulation of the immune system. PD-1 (programmed cell death-1) is a receptor, while PD-L1 (programmed death ligand-1) is a ligand that binds to the PD-1 receptor and ensures that immune responses occur only at the appropriate time5. PD-1 receptors are found on certain cells of the immune system called T cells. PD-L1 and PD-L2 are proteins normally found on certain cells of the immune system and can be produced by certain cancer cells. PD-L1 and PD-L2 can attach to the PD-1 receptors, switching off the T cells. Bavencio (avelumab) attaches to the PD-1 receptors on T-cells and thus impedes the binding of the cancer cell with the T-cell via PD-L1 and PD-L2 ligands. In this way, Bavencio (avelumab) prevents cancer cells from switching off T cells and increases the ability of the immune system to kill cancer cells1.
Where has Bavencio (avelumab) been approved?
Bavencio (avelumab) was approved by:
Food and Drug Administration (FDA), USA:
March 23, 20171 with an accelerated approval for people over the age of 12 with metastatic Merkel cell carcinoma (MCC)
October 12, 20171 with an accelerated approval for adults with locally advanced or metastatic urothelial carcinoma
European Medical Agency (EMA), European Union, September 18, 20174, with a conditional approval for adult patients with metastatic Merkel cell carcinoma (MCC)
Therapeutic Goods Administration (TGA), Australia, January 3, 20186 for people over the age of 12 with metastatic Merkel cell carcinoma (MCC).
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Bavencio (avelumab) taken?
The standard dosage is:
10 mg/kg (milligram per kilogram of body weight) as an intravenous infusion over 60 minutes every 2 weeks1,3.
Premedicate for the first 4 infusions and subsequently as needed.
Complete information about Bavencio (avelumab) dosage and administration can be found in the official prescribing information listed in our resources section1,3.
Note: Please consult your treating doctor for personalised dosing.
Are there any known side effects or adverse reactions of Bavencio (avelumab)?
Common adverse reactions
Merkel cell carcinoma
The most common adverse reactions (≥ 20%) listed in the prescribing information include1,3:
fatigue (tiredness)
musculoskeletal pain
diarrhea
nausea (feeling sick)
infusion-related reaction
rash (skin reaction)
decreased appetite
peripheral edema (accumulation of fluid)
constipation.
Urothelial carcinoma
The most common adverse reactions (≥ 20%) listed in the prescribing information include1:
fatigue (tiredness)
infusion-related reaction
musculoskeletal pain
nausea (feeling sick)
decreased appetite
urinary tract infection.
Serious side effects
The serious adverse reactions listed in the prescribing information include1,3:
immune-mediated pneumonitis
immune-mediated hepatitis
immune-mediated colitis
immune-mediated endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, hyperglycaemia)
immune-mediated nephritis and renal dysfunction
other immune-mediated adverse reactions
infusion-related reactions.
Use in a specific population
Bavencio (avelumab) can be fatal for a fetus, it is advised to avoid pregnancies and breast-feeding, use effective contraception during treatment with Bavencio (avelumab) and for at least 1 month after the last dose of Bavencio (avelumab)1,3.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,3.
