Bavencio (avelumab)

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Bavencio (avelumab)

How to buy Bavencio: You can order Bavencio (avelumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer EMD Serono Inc.
Disease Skin Cancer
Indication Metastatic Merkel cell carcinoma (MCC)
Mode of Action PD-L1 blocking antibody (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA)
Strength 20 mg/mL

Who is avelumab for?

Bavencio (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) [1][3]. This is the first FDA-approved treatment for this rare, aggressive form of skin cancer [2].

Recommended dose

Complete information about Bavencio (avelumab) dosage and administration can be found here: [1][3].
The standard dosage is:
  • 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.
Consult your treating doctor for personalised dosing.

What is avelumab and how does it work?

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) [1][3].

Bavencio (avelumab) targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells) [2]

PD-1 receptors are 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 receptors, switching off the T cells. By attaching to the PD-1 receptors Bavencio (avelumab) prevents cancer cells from switching off T cells, thereby increasing the ability of the immune system to kill cancer cells [1].

What is avelumab's approval status?

Bavencio (avelumab) was approved by:
  • FDA (US) on March 23, 2017 [1]
  • EMA (EU) on September 18, 2017 [4]
for metastatic Merkel cell carcinoma (MCC).

The approval was based on a study (JAVELIN Merkel 200 trial) involving 88 patients with metastatic MCC whose disease had progressed on, or after chemotherapy was administered for distant metastatic disease. The overall response rate was 33 % (95 % CI: 23.3, 43.8) with 11.4 % complete responses [1][3]. The duration of response ranged from 2.8 months [1][3] to over 24.9 months [3], with 93 % of patients having a response that lasted for at least 6 months and 71 % of patients having a response that lasted for at least 12 months [3].

The most common side effects with avelumab include tiredness, nausea, diarrhoea, decreased appetite, constipation, infusion-related reactions, weight loss and vomiting. Serious side effects include immune-related and infusion-related reactions, anaemia (low red blood cell counts), difficulty breathing and abdominal pain [4].
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