BAVENCIO

What it is

BAVENCIO (avelumab) is a concentrated solution for injection administered as an intravenous infusion. Each 10 mL vial contains 200 mg of avelumab, with each millilitre of concentrate containing 20 mg of avelumab.

Approved indications

— Treatment of adults and paediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). — First-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy. — First-line treatment of patients with advanced renal cell carcinoma (RCC) in combination with axitinib.

Dosing overview

Patients must be premedicated with an antihistamine and paracetamol prior to the first 4 infusions of BAVENCIO. If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician. Dose escalation or reduction is not recommended.

Key safety warnings

Infusion-related reactions, which might be severe, have been reported in patients receiving avelumab. Patients should be monitored for signs and symptoms of infusion-related reactions including pyrexia, chills, flushing, hypotension, dyspnoea, wheezing, back pain, abdominal pain, and urticaria. For Grade 3 or Grade 4 infusion-related reactions, the infusion should be stopped and avelumab should be permanently discontinued. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients treated with avelumab. While immune-mediated adverse reactions usually occur during treatment, symptoms can also manifest after discontinuation. Most immune-mediated adverse reactions occurring during treatment with avelumab as a single agent or in combination with axitinib were reversible and managed with temporary or permanent discontinuation of avelumab, administration of corticosteroids and/or supportive care. Immune-mediated pneumonitis including fatal outcome has been reported in patients receiving avelumab. Immune-mediated hepatitis including fatal outcome has been reported in patients receiving avelumab. Immune-mediated myocarditis including fatal outcome has been reported in patients receiving avelumab. Immune-mediated pancreatitis including fatal outcome has been reported in patients receiving avelumab. BAVENCIO in combination with axitinib can cause severe and fatal cardiovascular events. Major adverse cardiovascular events (MACE) occurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3–4 myocardial infarction (2.8%), and Grade 3–4 congestive heart failure (1.8%).

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

PBS listing

BAVENCIO solution concentrate for intravenous infusion 200 mg in 10 mL is listed on the PBS with 8 items under streamlined restriction at an ex-manufacturer price of A$1289.49.

Regulatory history

BAVENCIO (avelumab) 200 mg/10 mL concentrated solution for intravenous infusion was first listed on the ARTG on 3 January 2018. The TGA approved BAVENCIO on 2 January 2018 for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel Cell Carcinoma, based on demonstrated tumour response rate and duration of response in a single arm study. In July 2018, the PBAC recommended BAVENCIO for metastatic Merkel cell carcinoma with streamlined authority required listing under Section 100 (Efficient Funding of Chemotherapy), acknowledging high unmet need and improved survival rates. In March 2021, the PBAC recommended BAVENCIO for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma and for first-line treatment of Stage IV clear cell variant renal cell carcinoma in combination with axitinib. In July 2024, the PBAC rescinded its March 2021 recommendation for Stage IV clear cell variant renal cell carcinoma.