New FDA Approvals: The FDA Approved Amneal’s Alymsys
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May 12, 2022
April 13: The FDA approved Amneal Pharmaceuticals, Inc.’s Alymsys (bevacizumab-maly) for the treatment of multiple conditions: (1) first- or second-line treatment of metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy; (2) second-line treatment of metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy in people who have progressed on a first-line bevacizumab product; (3) first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel; (4) recurrent glioblastoma in adults; (5) metastatic renal cell carcinoma in combination with interferon alfa; (6) persistent, recurrent or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan; and (7) epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for platinum-resistant recurrent disease in people receiving no more than two prior chemotherapy regimens. The vascular endothelial growth factor inhibitor is the third biosimilar of Roche Group member Genentech USA, Inc.’s Avastin (bevacizumab) that the agency has approved. Dosing of the intravenous infusion is based on indication. Read more
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