Taiho Oncology progresses sNDA for Lonsurf in colorectal cancer

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for Lonsurf (trifluridine/tipiracil), Taiho Oncology Inc and Taiho Pharmaceutical, subsidiaries of Japanese drugmaker Otsuka Holdings (TYO: 4578), have revealed.

Lonsurf is intended as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

A Priority Review designation by the FDA reduces the review period of the sNDA by four months. In this case, the FDA provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of August 13, 2023.