Drug updated on 12/11/2024
| 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.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Pafolacianine, used with near-infrared imaging, successfully identified additional cancerous tissues in 33.0% of patients with ovarian cancer during cytoreductive surgery (95% confidence interval (CI), 24.3–42.7; P < .001), surpassing the predefined efficacy threshold of 10%.
- Among patients who underwent interval debulking surgery, the detection rate was higher at 39.7% (95% CI, 27.0–53.4; P < .001), with a sensitivity of 83% and a false-positive rate of 24.8%.
- Complete R0 resection, indicating no visible cancer left after surgery, was achieved in 62.4% of patients (68 of 109).
- Drug-related adverse events were reported in 30% of patients (45 out of 150), with the most common events being nausea, vomiting, and abdominal pain.
- No drug-related serious adverse events or deaths were reported in the study.
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 |
|---|---|---|---|
| A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006) | 140Subjects F: 100% M: 0% | 2023 | Journal of Clinical Oncology |
Sex Distribution:
F:100%
M:0%
140Subjects
Year:
2023
Source:Journal of Clinical Oncology