GRAM Congratulates On Target Laboratories on FDA Approval of Targeted Fluorescent Imaging Agent for Identification of Ovarian Cancer During Surgery
Michigan-based CDMO supports the manufacture of the prescription medication
December 10, 2021 – Grand River Aseptic Manufacturing (“GRAM”), a leading parenteral contract development and manufacturing organization (CDMO), is pleased to congratulate On Target Laboratories, Inc., on their recent U.S. Food and Drug Administration (FDA) approval of CYTALUXTM. On Target is a privately held biotechnology company developing fluorescent imaging agents to target and illuminate cancer during surgery. The FDA approved CYTALUX for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
“GRAM commends On Target Laboratories for their dedication to their mission to make cancer visible during surgery so it can be removed more completely,” said GRAM President and CEO Tom Ross. “It takes passion and determination to manufacture safe, pure drug products and the work On Target has done in serving patients is inspiring. We look forward to supporting the manufacture of CYTALUX for commercial use.”
The optical imaging agent is given to adult ovarian cancer patients prior to surgery to help surgeons find and remove ovarian cancer lesions that may otherwise be missed during surgery. CYTALUX is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal.
GRAM is outfitted with the technology, experience, systems, and processes that take injectable drug products from clinical trials to commercialization. Innovative equipment and modern facilities support pharmaceutical development and manufacturing in Grand Rapids, MI.
About Grand River Aseptic Manufacturing, Inc.
Grand River Aseptic Manufacturing, Inc. (“GRAM”), a leading parenteral contract development and manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics, small molecules and vaccines, GRAM’s advanced technology and staff supports pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.
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Contact:
Chelsea Keeton
(616) 678-2400
ckeeton@grandriverasepticmfg.com
Source:
Grand River Aseptic Manufacturing
Related Links:
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CYTALUX Indication
CYTALUX is an FDA-approved optical imaging agent indicated in adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions.
CYTALUX Important Safety Information
Infusion-Related Reactions
Adverse reactions consisting of nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, and itching were reported during the administration of CYTALUX. Your doctor may treat you with antihistamines and/or anti-nausea medication.
Pregnancy
CYTALUX may cause fetal harm when administered to a pregnant woman. There are no available human data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Contact your healthcare provider with a known or suspected pregnancy.
Folate Supplement Usage
Folic acid may reduce the detection of cancerous tissue with CYTALUX. Patients should stop taking folate, folic acid, or folate-containing supplements 48 hours before administration of CYTALUX.
Risk of Misinterpretation
Errors may occur with the use of CYTALUX. Sometimes cells may light up even if they are not cancerous or those that are cancerous may not light up. Also, cancerous or non-cancerous cells from other areas may light up, such as areas of the bowel, kidneys, lymph nodes, and inflamed tissue.
Adverse Reactions
The most common side effects of CYTALUX reported in clinical trials were nausea, vomiting, abdominal pain, flushing, indigestion, chest discomfort, itching, and allergic reaction during administration or infusion.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CYTALUX. For more information, ask your healthcare provider.
Call your doctor for medical advice about side effects. You may report side effects to On Target Laboratories at 1-844-434-9333 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Click here to see full Prescribing Information