Update: News from the FDA: Updates on breast cancer treatment

Relevance: Medium

Research Timeline: Post Approval

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What is this update about?

This three-part update includes information on the risks associated with BioZorb Markers in breast tissue, a new imaging drug and information on the FDA Oncology Podcast Series.

BioZorb Markers

The FDA issued a safety communication regarding BioZorb Markers, devices placed in soft tissue such as the breast. These markers help healthcare providers precisely identify where cancerous tissue was removed by surgery. This can help guide doctors to ensure that future medical procedures, such as radiation or surgery, focus on the right area.

The BioZorb Marker and BioZorb LP Marker have two parts: 1) a biodegradable framework that dissolves and is completely absorbed into the body in one year or longer, and 2) six titanium metal clips that permanently remain in the body.

Risks with the use of BioZorb Markers in breast tissue 

The FDA issued a Class I recall for BioZorb Markers. A Class I recall is the most serious type of recall. The recall resulted from reports of adverse reactions to BioZorb Markers in breast tissue.

Adverse reactions included:

• infection
• fluid buildup
• movement of the marker, either through the skin or to another location in the breast
• discomfort due to feeling the device in the breast
• rash

This recall is a correction, not a product removal, which means that people who have a BioZorb Marker will receive an alert. The FDA requires the manufacturer (Hologic, Inc.) of BioZorb Markers to notify customers of the risks when this device is placed in breast tissue. The FDA Safety Communication included a letter from Hologic Inc. to their customers, which can be read here.

Why is this update important?

If you have a BioZorb Marker (BioZorb Marker or BioZorb LP Marker) in your breast tissue, it is important to know what adverse reactions may occur. Talk to your healthcare provider if you have been having any symptoms that may be linked to these markers. 

The FDA encourages you to report problems or complications with a BioZorb Marker using the MedWatch Voluntary Reporting Form. This helps improve patient safety.

The FDA will continue to monitor reports of adverse events and keep the public informed if any new information becomes available.

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

New Imaging Drug

The FDA has approved the imaging drug, Lumisight (pegulicianine), to help surgeons remove all of the cancer tissue during a lumpectomy.  Lumisight is a fluorescent imaging drug injected into the vein before a lumpectomy and is used with FDA-approved fluorescent imaging devices. Together, these allow surgeons to better find and remove any remaining cancer during surgery.

The study, which led to the FDA approval, looked at 357 female breast cancer patients who were undergoing lumpectomies. The imaging device, Lumicell Direct Visualization System, was used to look inside the lumpectomy cavity during surgery to see if the Lumisight dye lit up any areas that could contain tumor tissue that was not removed during the procedure.

Lumicell imaging was correct 95 percent of the time when used with the Lumisight dye. This means that it correctly found leftover cancer in the lumpectomy cavity.

If imaging suggests that cancerous cells remain in the lumpectomy cavity, the surgeon then removes additional tissue.

The most important adverse reaction to Lumisight was hypersensitivity (1.4%), including anaphylaxis (a severe life-threatening allergic reaction in 0.6% of participants). This led to a boxed warning that is included in Lumisight’s prescribing information.

Why is this update important?

Lumicell with Lumisight dye can increase breast surgeons’ confidence that they have removed all of the cancer. This means that some patients may have less invasive surgery. It may also decrease the possibility of having additional surgeries. 

FDA Oncology Podcast

"Conversations on Cancer" is a public podcast series by the FDA Oncology Center of Excellence Project Community. The podcast explores social issues related to cancer with diverse panel members.  Panel members, including patients, share perspectives and experiences with a wide variety of topics related to cancer. These podcasts are for patients and healthcare providers.

In October 2023, during Breast Cancer Awareness Month, the podcast series featured its first-ever international collaboration. Panelists discussed the experiences of patients living with metastatic breast cancer. The podcast also featured some patients’ oncologists who discussed more of the science behind treatments and why they were chosen for that patient's cancer care.

Tune in this October 2024 for another insightful discussion on breast cancer!

Explore the FDA Oncology Center of Excellence podcasts on YouTube to listen to previous Conversations on Cancer episodes or attend upcoming conversations virtually. Click this link to learn more.

Why is this update important?

During the FDA Conversations on Cancer podcasts, oncologists and patients share their experiences with various personalized treatment plans and clinical trials that may help you or your family navigate a cancer journey. It may be helpful to you to listen to other people’s stories and professionals’ perspectives on various treatment options.

What does this mean for me?

The FDA is responsible for protecting public health. The agency achieves this by reviewing and approving treatments and products to ensure that they are safe and effective.  These FDA updates provide you with the latest information to help you stay informed.

Reference

Food and Drug Administration (FDA). BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication. May 22, 2024.

Food and Drug Administration (FDA). Approves Imaging Drug to Assist in Detection of Cancerous Tissue Following Lumpectomy. March 17, 2024.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 8/16/24