Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; 3.2 mg/1.6 mL (2 mg/mL)) |
| Drug Class | Optical imaging agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer.
- • Indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
Summary
- Pafolacianine (Cytalux) is used as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer and also for identifying malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer.
- Two randomized controlled trials were reviewed to gather information about the effectiveness and safety of pafolacianine (Cytalux).
- In a Phase 3 trial involving 112 patients, intravenous administration of pafolacianine within 24 hours before surgery resulted in clinically significant events reflecting meaningful changes in surgical operations among 53% participants compared to a prespecified limit of 10%.
- The study found that intraoperative molecular imaging using pafolacianine helped surgeons locate primary nodules they could not find using white light and palpation alone, occurring in approximately one-fifth (19%) of subjects.
- Additionally, this method revealed occult synchronous malignant lesions undetected by conventional methods in 8% of subjects; most discovered malignancies were outside the planned resection field, which led to alterations in the overall scope of the surgical procedure for 29 of the subjects.
- No drug-related serious adverse events occurred during these studies indicating that use of pafolacianine was safe under these conditions; however no specific subgroup considerations were mentioned across both documents reviewed regarding its usage or effects on different population types.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Cytalux (pafolacianine) Prescribing Information. | 2022 | On Target Laboratories, Inc., West Lafayette, IN |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. | Data not availableSubjects F: null% M: null% | 2023 | The Journal of Thoracic and Cardiovascular Surgery |
| A phase III study of pafolacianine injection (otl38) for intraoperative imaging of folate receptor–positive ovarian cancer (study 006). | Data not availableSubjects F: null% M: null% | 2022 | Journal of Clinical Oncology |
Document Title
Sex Distribution:
Year:
2023
Source:The Journal of Thoracic and Cardiovascular Surgery
Sex Distribution:
Year:
2022
Source:Journal of Clinical Oncology