Tag Archives: Surgery

Drug Information Update – FDA approves expanded use of drug to reduce the risk of melanoma returning after surgery

Drug Information Update – FDA approves expanded use of drug to reduce the risk of melanoma returning after surgery
FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

On October 28, 2015, the U.S. Food and Drug Administration expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.

Yervoy, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery. Yervoy is a monoclonal antibody that blocks a molecule known as CTLA-4 (cytotoxic T-lymphocyte antigen). CTLA-4 may play a role in slowing down or turning off the body’s immune system, and affects its ability to fight off cancerous cells. Yervoy may work by allowing the body’s immune system to recognize, target and attack cells in melanoma tumors.

The safety and effectiveness of Yervoy for this new use were studied in 951 patients who received Yervoy or a placebo as adjuvant therapy following complete surgical removal of melanoma. The study measured the amount of time after treatment it took for the cancer to come back (“recurrence-free survival”) and overall survival. Forty-nine percent of participants taking Yervoy had their cancer return after an average of 26 months, compared to 62 percent of those receiving a placebo, whose cancer returned after an average of 17 months. The analysis of overall survival data has not yet occurred.

The most common side effects of Yervoy in this study were rash, diarrhea, fatigue, itching, headache, weight loss and nausea. Yervoy can also cause autoimmune disease in the digestive system, liver, skin, nervous system (which would each require treatment with
corticosteroids), as well as in the hormone-producing glands (which requires life-long hormone replacement therapy). Women who are pregnant should not take Yervoy because it may cause harm to a developing fetus.

Due to the potential for fatal immune-mediated adverse reactions and unusual severe side effects with Yervoy, the label includes a Boxed Warning. A Medication Guide will also be provided to patients to inform them about the therapy’s potential side effects.

For more information, please visit: Yervoy

Bioprosthetic Aortic Valves: FDA Notification – Reduced Leaflet Motion

Bioprosthetic Aortic Valves: FDA Notification – Reduced Leaflet Motion CardioBeat

Information for patients about FDA cardiovascular-related product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances.

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Bioprosthetic Aortic Valves: FDA Notification – Reduced Leaflet Motion

*AUDIENCE*: Cardiology, Surgery, Risk Manager

*ISSUE*: The FDA is aware of recent reports regarding reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR and TAVR devices. Importantly, most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis.

The definitive cause(s) of reduced leaflet motion in some bioprosthetic aortic valves also is not known. Evidence from imaging studies suggests that blood clot (thrombus) deposits on the leaflets may cause restricted motion. The prevalence of reduced leaflet motion was less in patients receiving therapeutic anticoagulation with warfarin compared with those receiving sub-therapeutic or no anticoagulation and with those receiving dual anti-platelet therapy.

In one study, treatment with blood thinning medications (anticoagulants) resulted in the resolution of the leaflet motion abnormalities.

At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications. This view is supported by the favorable benefit/risk profile observed in SAVR devices in the 30 years they have been on the market and in TAVR devices in the 8 years they have been in use.

*BACKGROUND*: These reports have raised important questions about bioprosthetic aortic valves. However, limited available data do not allow FDA to fully characterize the causes, incidence, and short and long-term risks of reduced valve leaflet motion, or to recommend appropriate treatment. The FDA is working with the American College of Cardiology, the Society of Thoracic Surgeons, and the device manufacturers to design clinical studies to fully evaluate reduced valve leaflet motion for all types of bioprosthetic aortic valves.

*RECOMMENDATION*: For patients who have a bioprosthetic aortic valve, additional diagnostic imaging using 3D or 4D CT or TEE may be considered when clinically indicated. If reduced leaflet motion is found, treatment options should be discussed with the team of heart physicians responsible for the patient’s care.

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with bioprosthetic aortic valves. If you suspect or experience a problem with a bioprosthetic aortic valve, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

* Complete and submit the report Online: http://www.fda.gov/MedWatch/report

* Download form

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA
Notification, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm465729.htm

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