Pafolacianine

This Phase III confirmatory study of 150 patients (109 with folate receptor-positive ovarian cancer in efficacy analysis) demonstrated that pafolacianine with near-infrared imaging identified additional cancer lesions not detected by standard white light assessment and palpation in 33% of patients, exceeding the prespecified 10% threshold. The agent achieved 83% sensitivity for detecting ovarian cancer with a 24.8% patient false-positive rate, and complete R0 resection was achieved in 62.4% of patients.

FDA approval documentation summarizing the efficacy evaluation from study NCT03180307 involving 178 women with ovarian cancer, where 26.9% of patients had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection, with a patient-level false positive rate of 20.2%.

This Phase III confirmatory study of 150 patients (109 with folate receptor-positive ovarian cancer in efficacy analysis) demonstrated that pafolacianine with near-infrared imaging identified additional cancer lesions not detected by standard white light assessment and palpation in 33% of patients, exceeding the prespecified 10% threshold. The agent achieved 83% sensitivity for detecting ovarian cancer with a 24.8% patient false-positive rate, and complete R0 resection was achieved in 62.4% of patients.

FDA approval documentation summarizing the efficacy evaluation from study NCT03180307 involving 178 women with ovarian cancer, where 26.9% of patients had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection, with a patient-level false positive rate of 20.2%.

FDA approval documentation summarizing the efficacy evaluation from study NCT03180307 involving 178 women with ovarian cancer, where 26.9% of patients had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection, with a patient-level false positive rate of 20.2%.

This Phase III confirmatory study of 150 patients (109 with folate receptor-positive ovarian cancer in efficacy analysis) demonstrated that pafolacianine with near-infrared imaging identified additional cancer lesions not detected by standard white light assessment and palpation in 33% of patients, exceeding the prespecified 10% threshold. The agent achieved 83% sensitivity for detecting ovarian cancer with a 24.8% patient false-positive rate, and complete R0 resection was achieved in 62.4% of patients.

FDA approval documentation summarizing the efficacy evaluation from study NCT03180307 involving 178 women with ovarian cancer, where 26.9% of patients had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection, with a patient-level false positive rate of 20.2%.

FDA approval documentation summarizing the efficacy evaluation from study NCT03180307 involving 178 women with ovarian cancer, where 26.9% of patients had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection, with a patient-level false positive rate of 20.2%.

FDA approval documentation summarizing the efficacy evaluation from study NCT03180307 involving 178 women with ovarian cancer, where 26.9% of patients had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection, with a patient-level false positive rate of 20.2%.

FDA approval documentation summarizing the efficacy evaluation from study NCT03180307 involving 178 women with ovarian cancer, where 26.9% of patients had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection, with a patient-level false positive rate of 20.2%.