Taiho Oncology announced that the FDA accepted for Priority Review its supplemental new drug application (sNDA) for Lonsurf® (trifluridine/tipiracil) in combination with bevacizumab for metastatic colorectal cancer (mCRC). The sNDA is based on results of a phase III clinical trial which combined Lonsurf® with Genentech’s Avastin® (bevacizumab), which saw improved survival and progression-free survival over Lonsurf® alone. The FDA expects to decide on the sNDA by 13 August 2023.
Last year Genentech and Samsung Bioepis settled their US BPCIA Avastin® bevacizumab patent dispute.