Alymsys FDA Approval History
FDA Approved: Yes (First approved April 13, 2022)
Brand name: Alymsys
Generic name: bevacizumab-maly
Dosage form: Injection
Company: Amneal Pharmaceuticals LLC
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Alymsys (bevacizumab-maly) is a vascular endothelial growth factor inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer; non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Alymsys (bevacizumab-maly) is indicated for the treatment of:
- Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
- Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
- First-Line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel.
- Recurrent glioblastoma in adults.
- Metastatic renal cell carcinoma in combination with interferon alfa.
- Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel.
Alymsys is not indicated for adjuvant treatment of colon cancer.
- The important safety information for Alymsys includes warnings and precautions on severe and fatal hemorrhage; arterial and venous thromboembolic events; hypertension, hypertensive crisis, and hypertensive encephalopathy; renal injury, proteinuria, and nephrotic syndrome; posterior reversible encephalopathy syndrome; embryo-fetal toxicity; ovarian failure; congestive heart failure; gastrointestinal perforations and fistula; surgery and wound healing complications, and infusion-related reactions.
- Reported adverse drug reactions in patients include epistaxis, hemorrhage, hypertension, exfoliative dermatitis, proteinuria, back pain, headache, rhinitis, taste alteration, dry skin, and lacrimation disorder.
- Alymsys is the third approved biosimilar for Avastin following Mvasi (bevacizumab-awwb) in 2017 and Zirabev (bevacizumab-bvzr) in 2019.
Development timeline for Alymsys
| Date | Article |
|---|---|
| Apr 13, 2022 | Approval FDA Approves Alymsys (bevacizumab-maly), a Biosimilar to Avastin |
Further information
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