FDA accepts for priority reviewsNDA for the use of Lonsurf + bevacizumab forrefractory metastatic colorectal cancer
Taiho Pharmaceutical Co., Ltd. and Taiho Oncology, Inc. announced that the FDA has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (Lonsurf) 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 antiEGFR 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.
Results from the SUNLIGHT trial were presented by Professor Josep Tabernero, MD, PhD, Head of Medical Oncology, Val d’ Hebron University Hospital, Barcelona, Spain, and Principal Investigator for the SUNLIGHT trial, at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), held January in San Francisco.
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