First Biosimilar For Cancer Treatment Approved
The Food and Drug Administration (FDA) has approved Mvasi (bevacizumab-awwb; Amgen) as a biosimilar to Avastin (bevacizumab; Genentech) to treat certain colorectal, lung, brain, kidney and cervical cancers, making it the first biosimilar for cancer treatment to be approved in the U.S.
The approval was based on evidence from animal study data, human pharmacokinetic and pharmacodynamics data, and clinical immunogenicity data which demonstrated Mvasi as a biosimilar to Avastin. Specifically, Mvasi is indicated to treat:
- Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment.
- Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen.
- Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
- Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate.
- Metastatic renal cell carcinoma, in combination with interferon alfa.
- Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
The Mvasi label contains a Boxed Warning concerning an increased risk of gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal hemorrhage. Patients should stop using Mvasi if these side effects become severe or life-threatening.
For more information visit FDA.gov.