Drug updated on 9/4/2024
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.
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Summary
- Cytalux (pafolacianine) is indicated as an adjunct for intraoperative identification of malignant lesions in adult patients with ovarian cancer, and for intraoperative identification of malignant and non-malignant pulmonary lesions in adult patients with known or suspected lung cancer.
- This summary is based on the review of two randomized controlled trial(s). [1-2]
- Lung Cancer: Clinically significant events were observed in 53% of participants, surpassing the prespecified threshold of 10% (P < .0001). Pafolacianine identified margins 10 mm or less from the resected nodule in 38% of participants, and intraoperative molecular imaging detected primary nodules not visible by white light and palpation in 19% of cases.
- Ovarian Cancer: Pafolacianine identified additional cancer in 33% of patients, exceeding the prespecified threshold of 10% (P < .001). Sensitivity for detecting ovarian cancer was 83%, with a 24.8% false-positive rate, and a complete R0 resection was achieved in 62.4% of patients.
- Lung Cancer: No drug-related serious adverse events occurred; studies suggest a favorable safety profile but do not specify non-serious adverse events.
- Ovarian Cancer: Drug-related adverse events occurred in 30% of patients, primarily nausea, vomiting, and abdominal pain; no drug-related serious adverse events or deaths were reported.
- There is no population type or subgroup information available in the reviewed studies.
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). | 150Subjects F: 100% M: 0% | 2022 | Journal of Clinical Oncology |
Document Title
Sex Distribution:
Year:
2023
Source:The Journal of Thoracic and Cardiovascular Surgery
Sex Distribution:
F:100%
M:0%
150Subjects
Year:
2022
Source:Journal of Clinical Oncology