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Efficacy and Safety

 

Phase 3 (006 Study):
CYTALUX® FOR FR+ OVARIAN CANCER

Study Design

A Phase 3, randomized, single dose, open-label study to investigate the safety and efficacy of CYTALUX for intraoperative imaging of folate receptor positive ovarian cancer.

Efficacy

* Women highly suspicious for or with confirmed ovarian cancer who underwent both normal and fluorescent light evaluation (Intent-to-Image set); N=134, 95% CI [19.6, 35.2]

† Phase 3 (006 Study): CYTALUX FOR FR+ OVARIAN CANCER; N=58, 95% CI [27.0, 53.4]
This subgroup analysis utilized a smaller analysis set than the primary endpoint and was not adjusted to control for error, so the results are not conclusive and should be interpreted cautiously.

‡ Phase 3 (006 Study): Based on a prespecified exploratory endpoint for the proportion of subjects for whom the fluorescence surgical plan was changed based on fluorescence imaging both prior to initiation of the surgical procedure and upon re-imaging of the surgical field after surgical procedure prior to closing. (N=109, 95% CI [44.3,63.7])

Drug-Related Adverse Events

DRUG-RELATED ADVERSE EVENTSMild/Moderate
n (% n/N)		SEVERE
n (% n/N)
Subjects with at least one drug related TEAE43 (28.7%)2 (1.3%)
Total number of drug- related adverse events632
ZERO

drug-related serious adverse events were observed in any patient dosed with CYTALUX.

MOST COMMON DRUG-RELATED
ADVERSE EVENTS		MILD/MODERATE
n (% n/N)		SEVERE
n (% n/N)
Nausea27 (18.0%)0
Vomiting8 (5.3%)0
Abdominal Pain7 (4.7%)0
0%

of all drug-related adverse events were mild-to-moderate.

ZERO

drug-related serious adverse events were observed in any patient dosed with CYTALUX.

0%

of all drug-related adverse events were mild-to-moderate.

N=150 study subjects infused with CYTALUX

Misinterpretation of Camera Images

Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

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about CYTALUX and how to bring this technology to your OR.

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INDICATION

CYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of:

  • Malignant lesions in adult patients with ovarian cancer.
  • Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX.

Important Safety Information and Indication for Cytalux® Important Safety Information for Cytalux®

INDICATION AND USAGE
CYTALUX® is an FDA approved optical imaging agent indicated as an adjunct for intraoperative identification of:

  • Malignant lesions in adult patients with ovarian cancer.
  • Malignant and non-malignant pulmonary lesions in adult patients with known or suspected cancer in the lung.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Infusion-Related Reactions
Adverse reactions including nausea, vomiting, abdominal pain, flushing, hypersensitivity, elevation in blood pressure, dyspepsia, and chest discomfort were reported in patients receiving CYTALUX in clinical studies. A total of 17% of patients experienced reactions during administration of CYTALUX. Reactions typically occurred within 15 minutes of the start of infusion. CYTALUX infusion interruption or discontinuation due to adverse reactions occurred in 11% of all patients. Treatment with antihistamines and/or anti-nausea medication may be used. If an adverse reaction occurs during administration, the infusion can be interrupted and resumed after treatment of the reaction.

Risk of Misinterpretation
Errors may occur with the use of CYTALUX during intraoperative fluorescence imaging to detect ovarian cancer and lesions in the lung, including false negatives and false positives. Non-fluorescing tissue in the surgical field does not rule out the presence of ovarian cancer or lesions in the lung. Fluorescence may be seen in normal tissues including bowel, kidneys, lymph nodes, lungs, and inflamed tissue.

Embryo-Fetal Toxicity
Based on its mechanism of action, CYTALUX may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating CYTALUX treatment.

Risk of Pafolacianine Aggregation and Infusion Reactions
Use of the incorrect diluent to prepare the CYTALUX infusion solution can cause the aggregation of pafolacianine; aggregation may induce infusion reactions such as nausea, vomiting, abdominal pain or rash.  Use only 5% Dextrose Injection to prepare the CYTALUX infusion solution. Do not use other diluents.

DRUG INTERACTIONS
Use of folate, folic acid, or folate-containing supplements may reduce binding of pafolacianine to folate receptors and could reduce the detection of lesions with CYTALUX. Avoid administration of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX

ADVERSE REACTIONS
The safety of CYTALUX was evaluated in four open label clinical studies, two studies (N = 44 and N = 150) in patients with ovarian cancer and two studies (N = 100 and N = 112) in patients with known or suspected cancer in the lung. A total of 406 patients received 0.025 mg/kg of CYTALUX via intravenous administration.

Adverse reactions that occurred in ≥ 1% of patients were: nausea (13%), vomiting (5%), abdominal pain (2%), flushing (2%), other infusion-related reactions (2%), hypersensitivity (2%), elevation in blood pressure (1%), dyspepsia (1%), and chest discomfort (1%). Adverse reactions occurred during the administration of CYTALUX in 17% of patients.

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