VEGZELMA

What it is

VEGZELMA is a biosimilar medicine highly similar to the innovator product Avastin. Bevacizumab is the active ingredient. VEGZELMA is available in 100 mg and 400 mg single dose vials containing 4 mL and 16 mL, respectively, of bevacizumab (25 mg/mL). VEGZELMA is a clear to slightly opalescent, colourless to pale brown, sterile solution for intravenous (IV) infusion. Bevacizumab is a recombinant humanised monoclonal antibody that selectively binds to and neutralises the biologic activity of human vascular endothelial growth factor (VEGF).

Approved indications

— Metastatic colorectal cancer in combination with fluoropyrimidine-based chemotherapy. — Locally recurrent or metastatic breast cancer in combination with paclitaxel for first-line treatment in patients in whom anthracycline-based therapy is contraindicated. — Advanced, metastatic or recurrent non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel for first-line treatment of unresectable disease. — Advanced and/or metastatic renal cell cancer in combination with interferon alfa-2a. — Grade IV glioma as a single agent after relapse or disease progression after standard therapy. — Advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages IIIB, IIIC and IV) in combination with carboplatin and paclitaxel for first-line treatment. — First recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine in patients who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors. — Recurrent platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin in patients who have received no more than two prior chemotherapy regimens and have not received prior anti-angiogenic therapy. — Persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin. — Persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and topotecan where cisplatin is not tolerated or not indicated.

Dosing overview

For metastatic colorectal cancer, the recommended dose is 5 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg of body weight given once every 3 weeks for first-line treatment; 10 mg/kg of body weight given every 2 weeks or 15 mg/kg of body weight given once every 3 weeks for second-line treatment. For locally recurrent or metastatic breast cancer, the recommended dose is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks. For advanced, metastatic or recurrent non-squamous non-small cell lung cancer, the recommended dose is 15 mg/kg of body weight given once every 3 weeks in combination with carboplatin and paclitaxel. For advanced and/or metastatic renal cell cancer, the recommended dose is 10 mg/kg given once every 2 weeks. For Grade IV glioma, the recommended dose is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks. For first-line epithelial ovarian, fallopian tube or primary peritoneal cancer, the dose is 15 mg/kg of body weight given once every 3 weeks, with treatment continued for a total of 15 months or until disease progression. For cervical cancer, the recommended dose is 15 mg/kg of body weight given once every 3 weeks.

Key safety warnings

Patients may be at increased risk for gastrointestinal perforation and gallbladder perforation when treated with VEGZELMA, and it should be permanently discontinued if perforation develops. An increased incidence of hypertension has been observed in patients treated with VEGZELMA, with the incidence likely dose-dependent, and pre-existing hypertension should be adequately controlled before starting treatment. Patients treated with VEGZELMA have an increased risk of haemorrhage, especially tumour-associated haemorrhage, and it should be permanently discontinued if Grade 3 or 4 bleeding occurs. An increased incidence of arterial thromboembolic events including cerebrovascular accidents, myocardial infarction and transient ischaemic attacks has been observed, ranging up to 5.9% in VEGZELMA-containing arms compared with up to 1.7% in control arms. Patients with a history of hypertension may be at increased risk for proteinuria development, which may be dose-dependent, and testing for proteinuria is recommended prior to starting VEGZELMA therapy.

Contraindications

VEGZELMA is contraindicated in patients with known hypersensitivity to any components of the product, Chinese hamster ovary cell products or other recombinant human or humanised antibodies.

Regulatory history

VEGZELMA (bevacizumab) 100 mg/4 mL and 400 mg/16 mL solutions for intravenous infusion were first listed on the Australian Register of Therapeutic Goods on 5 September 2023. VEGZELMA was approved for registration in Australia as a biosimilar medicine, with the TGA concluding that it is highly similar to the innovator product Avastin and approving it for all the same indications as Avastin in Australia. The TGA evaluated VEGZELMA using evaluation reports from the European Medicines Agency via the COR-B process, which confirmed biosimilarity to Avastin and supported approval for the proposed indications.