Tukysa + trastuzumab granted priority review by FDA for previously treated HER2-positive metastatic colorectal cancer
Seagen Inc. announced that the FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) seeking accelerated approval for Tukysa (tucatinib) in combination with trastuzumab for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease
The sNDA submission is based on the results of the pivotal phase II MOUNTAINEER trial. These data were presented at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in July 2022.
“There are currently no FDA-approved therapies for metastatic colorectal cancer that specifically target HER2,” said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. “The FDA’s prioritization of our application for tucatinib in combination with trastuzumab supports our belief in its significant potential to benefit people with previously treated HER2-positive metastatic colorectal cancer.”
The FDA grants Priority Review to applications for medicines that, if approved, would provide significant improvements in safety or effectiveness of the treatment, diagnosis or prevention of serious diseases. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of January 19, 2023. In July 2022, the FDA granted Breakthrough Therapy Designation for tucatinib in combination with trastuzumab for the treatment of adult patients with unresectable or metastatic HER2-positive colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy based on results from the MOUNTAINEER trial.
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