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November 15, 2021 – Mvasi® (bevacizumab-awwb) has received a new indication to treat epithelial ovarian, fallopian tube, or primary peritoneal cancer. The drug, manufactured by Amgen, is a biosimilar for Genentech's Avastin® (bevacizumab).
- Under the new indication, Mvasi is FDA approved for use in combination with:
- Carboplatin and paclitaxel, followed by Mvasi a single agent, for stage III or IV disease following initial surgical resection;
- Paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease in patients who have received no more than two prior chemotherapy regimens; or
- Carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Mvasi as a single agent, for platinum-sensitive recurrent disease.
- The new indication mirrors an FDA-approved indication for Mvasi's reference product, Avastin.
- Recommend dosing and duration of treatment under the indication is based on individual patient factors such as treatment history, chemotherapy regimen, and disease state. Mvasi is administered by a healthcare provider via intravenous infusion over the course of 30-90 minutes, based on treatment tolerance.
- Mvasi first received U.S. FDA approval in 2017.