Update: News from the FDA– new breast cancer treatment, thermography warning and implant screening updates
This XRAY review is a summary of FDA breast cancer updates from July to December 2023. This includes a new drug approval and two consumer updates. (Posted 2/21/24)
Most relevant for: People with HR-positive and HER2-negative metastatic breast cancer. People with silicone breast implants. People considering thermography screening.
It may also be relevant for:
people with breast cancer
previvors
people with ER/PR + cancer
people with a genetic mutation linked to cancer risk
The approved Truqap (capivasertib) plus Faslodex (fulvestrant) for some people with advanced breast cancer. Faslodex is a type of hormone therapy that is given as an injection. Truqap is a pill taken orally.
The FDA approved this combination as a second treatment for people with locally advanced or HR-positive, breast cancer in the following situations:
People who were diagnosed with metastatic breast cancer that returned or worsened after treatment with hormone therapy.
People who were diagnosed with breast cancer whose cancer came back during their first treatment or within 12 months of completing it.
Tumor testing is performed before treatment is recommended. The new combination treatment is approved only for people whose tumor has a mutation in one of three genes: PIK3CA, AKT1 or . The FDA also approved the Foundation One CDx tumor test to identify people who are most likely to benefit from this new combination treatment.
Read more about this recent approval in our XRAY review here.
Screening for implant ruptures
Ruptures of silicone implants typically occur without symptoms. Because these “silent ruptures” do not usually change the way an implant looks or feels, it is unlikely that you will notice immediately and your healthcare provider may not be able to detect a rupture during a physical examination.
Magnetic resonance imaging () is the most effective way to look for a silent rupture. On December 14, 2023, the FDA update on Risks and Complications of Breast Implants added that can be used as an alternative to MRI screening for implant rupture.
Thermogram is no substitute for
A mammogram is a type of x-ray that looks for changes or cancer in the breast. The FDA regulates the machines used for and training for the technicians who administer mammograms.
Thermography is sometimes claimed to be an alternative method to . A thermogram uses heat to detect breast cancer on or near the surface of the body. However, the FDA is not aware of any scientific evidence that supports these claims. On October 6, 2023, the FDA stated that although thermography is approved for use in combination with a primary screening test, such as mammography, it is not approved for primary breast cancer screening.
The FDA also warned that some websites claim thermography can find breast cancer years before it would be detected through other types of screening. Some sites also claim that thermography can more effectively detect cancer in dense breasts than mammography. The FDA is not aware of any evidence that supports these claims.
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 2/21/24
Questions To Ask Your Doctor
Am I eligible for treatment with Truqap (capivasertib) plus Faslodex (fulvestrant)?
What type of screening should I have to make sure that my implant hasn’t ruptured?
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Relevance: Medium
This FDA approval and update is only relevant for some people:
People with locally advanced or metastatic HR-positive breast cancer.
People who have silicone breast implants.
People considering thermography instead of mammography to screen for breast cancer.
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