Pafolacianine is approved for identifying malignant ovarian cancer lesions

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Jan 2022: Pafolacianine (Cytalux, On Target Laboratories, LLC), an optical imaging agent, has been licenced by the Food and Drug Administration for adult patients with ovarian cancer as an adjuvant for interoperative detection of malignant lesions. Pafolacianine is a fluorescent medication that works by targeting the folate receptor, which is overexpressed in ovarian cancer. It’s employed using a Near-Infrared (NIR) fluorescence imaging system that’s been cleared by the FDA for pafolacianine-specific use.

In a single-arm, multicenter, open-label research (NCT03180307), 178 women diagnosed with ovarian cancer or with a strong clinical suspicion of ovarian cancer who were planned to have primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery were evaluated for efficacy. Pafolacianine was given to all of the patients. In addition to standard of care evaluations such as pre-surgical imaging, intraoperative palpation, and normal light examination of lesions, 134 patients got fluorescent imaging evaluation. At least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by routine visual or tactile inspection was found in 36 (26.9%) of these individuals. In the detection of ovarian cancer lesions confirmed by central pathology, the patient-level false positive rate of pafolacianine using NIR fluorescent light was 20.2 percent (95 percent CI 13.7 percent , 28.0 percent ).

Nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, pruritus, and hypersensitivity were the most prevalent adverse effects in patients (1%).

Pafolacianine is given intravenously over 60 minutes, 1 to 9 hours before surgery, at a dose of 0.025 mg/kg. Using folate, folic acid, or folate-containing supplements within 48 hours of receiving pafolacianine is not recommended.

View full prescribing information for Cytalux

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

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