FDA grants priority review to pafolacianine sodium injection for ovarian cancer surgery
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The FDA granted priority review to pafolacianine sodium injection as an intraoperative adjunct to help identify ovarian cancer during surgery, according to the agent’s manufacturer.
Nearly all ovarian cancers overexpress folate receptors to enable folic acid uptake.
Pafolacianine sodium injection (On Target Laboratories) — administered via IV before surgery — is a novel molecule that has been shown to bind to folate receptors and illuminate intraoperatively under near-infrared light, according to a manufacturer-issued press release. The goal is to help surgeons identify additional malignant tissue during the operation and provide greater certainty during complete resection.
Results of a phase 2 trial showed the agent helped surgeons detect additional lesions in nearly half (48.3%) of women with ovarian cancer.
“Our [new drug application] is supported by our positive phase 2 and phase 3 clinical trials,” Christopher Barys, president and CEO of On Target Laboratories, said in the release. “As we move closer to FDA approval for ovarian cancer, we are realizing our mission to intraoperatively visualize more cancer and extend the benefits of a complete resection to patients.”
The FDA previously granted orphan drug designation to pafolacianine sodium injection for use in ovarian cancer, as well as fast track designation for use in lung cancer.
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