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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)

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RELEVANCE

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

Relevance: Medium

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New Drug Approval

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

References

FDA approves Capivasertib with Fulvestrant for breast cancer. FDA news release November 16, 2023.