The drug was approved under the FDA’s Accelerated Approval Program based on the treatment success rate in previous clinical trials, according to a Jan. 19 news release from the company.
“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed following front-line therapy have had poor outcomes,” John Strickler, MD, an associate professor at Duke University Medical Center and lead investigator during clinical trials of the drug, said in the release. “The FDA approval of a chemotherapy-free combination regimen that specifically targets HER2 is great news for these patients.”
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