Medical World News® Inside the Practice: Phillip Low, PhD, on the Development and Approval of Pafolacianine

Approval Alert | <b>Pafolacianine for Ovarian Cancer Detection During Surgery</b>

CancerNetwork® spoke with Phillip Low, PhD, about the development and FDA approval of pafolacianine.

For the latest installment of the Inside the Practice Segment of the Medical World News® broadcast, CancerNetwork® spoke with Phillip Low, PhD, Presidential Scholar for Drug Discovery and Ralph C. Corley Distinguished Professor of Chemistry – Biochemistry at Purdue University, about the development of pafolacianine (Cytalux) for identifying malignant ovarian cancer lesions.

Pafolacianine is a fluorescent dye that is given intravenously prior to surgery that was approved by the FDA in November 2021.1 The agent targets the folate receptor that is overexpressed in ovarian cancer. During surgery, a near-infrared fluorescence imaging system is used to illuminate cancerous lesions.

Low discussed how the idea of this agent came to be, and the challenges he and his team overcame to begin clinical trials. A doctor from the Netherlands took interest in the agent, and when the study was published in Nature, investigators in the United States began to take interest.

Moving forward, Low hopes to see pafolacianine utilized in other types of cancers. Recently, use of pafolacianine was able to reach the primary end point of the phase 3 ELUCIDATE trial (NCT04241315) in lung cancer.2 In that study, the agent was used to identify pulmonary nodules and detect positive margins.

This segment comes from the CancerNetwork® portion of the MJH Life Sciences™ Medical World News®, airing daily on all MJH Life Sciences™ channels.

References

1. FDA approves pafolacianine for identifying malignant ovarian cancer lesions. News Release. FDA. November 29, 2021. Accessed January 14, 2022. https://bit.ly/3I7nv3K

2. On Target Laboratories completes ELUCIDATE phase 3 clinical trial investigating the use of CYTALUX (pafolacianine) injection in cancer in the lung. News Release. January 13, 2022. Accessed January 14, 2022. https://bit.ly/3rip48e