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The U.S. Food and Drug Administration (FDA) has recently approved three new treatment options for different types of metastatic (advanced) breast cancer. Together, the approvals show how treatment is becoming more tailored to tumor subtype, biomarker results, and what treatment a person has already had.
The three new treatments include:
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The Trodelvy approval expands how the drug can be used for unresectable locally advanced metastatic TNBC. “Unresectable” means a tumor can’t be safely removed with surgery.
The FDA has approved Trodelvy as a stand-alone treatment for people who aren’t eligible for PD-1 or PD-L1 inhibitor-based therapy. It’s also approved alongside pembrolizumab or berahyaluronidase alfa-pmph for people whose tumors express the protein PD-L1.
Trodelvy is a Trop-2-directed antibody-drug conjugate. It attaches to Trop-2, a protein found on many breast cancer cells, and delivers chemotherapy directly to those cells.
Trodelvy is given by intravenous (IV) infusion at a clinic.
In the ASCENT-03 trial, people who received Trodelvy alone lived a median of 9.7 months without their cancer getting worse, compared with 6.9 months for those who received standard chemotherapy. This measure is called progression-free survival (PFS).
In the ASCENT-04/KEYNOTE-D19 trial, people who received Trodelvy with pembrolizumab had a median PFS of 11.2 months, compared with 7.8 months for those who received chemotherapy plus pembrolizumab.
In both studies, more people in the Trodelvy groups had their tumors shrink. This was confirmed on a later scan.
Ibrance Moves Into Maintenance Treatment for HR-Positive, HER2-Positive DiseaseThe FDA also approved Ibrance as maintenance treatment for adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer whose cancer has not progressed after initial treatment with chemotherapy and HER2-targeted therapy. Ibrance may be given with trastuzumab, with or without pertuzumab, and endocrine (hormone) therapy.
Ibrance is already used to treat other types of HR-positive metastatic breast cancer. This new approval allows it to be used after initial treatment to help keep HR-positive, HER2-positive breast cancer under control.
Ibrance is a type of targeted therapy called a cyclin-dependent kinase (CDK) 4/6 inhibitor. It works by blocking proteins that help cancer cells grow and divide, which can slow the growth of the cancer.
The drug is taken by mouth as a capsule or tablet.
The approval was based on the PATINA trial. People who received Ibrance with trastuzumab-based maintenance treatment and endocrine therapy lived longer without their cancer getting worse than those who received trastuzumab-based maintenance treatment and endocrine therapy alone.
The hazard ratio was 0.76, meaning the Ibrance group had a 24 percent lower rate of cancer progression or death at any point during the study.
The newest of the three approvals is Revtorpyk. It may be used for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation (gene change). It may be given with fulvestrant, and with or without palbociclib. Revtorpyk is indicated for those whose cancer has progressed after at least one endocrine therapy for metastatic disease.
This approval gives people whose cancer has stopped responding to endocrine therapy a new targeted treatment option.
Revtorpyk is a type of targeted therapy called a kinase inhibitor. It blocks proteins in the PI3K/mTOR signaling pathway, which can help some breast cancer cells grow and survive.
The drug is given as an IV infusion.
The approval was based on the VIKTORIA-1 clinical trial. People who received Revtorpyk with fulvestrant and palbociclib lived a median of 9.3 months without their cancer getting worse, compared with two months for those who received fulvestrant alone.
People who received Revtorpyk with fulvestrant also lived a median of 7.4 months without their cancer getting worse, compared with two months for those who received fulvestrant alone.
Tumor shrinkage was also more common with Revtorpyk. About 32 percent of people who received the three-drug combination and 28 percent who received the two-drug combination had their tumors shrink, compared with 1 percent of those who received fulvestrant alone.
These approvals expand treatment choices across three different types of advanced breast cancer.
No drug is right for every person. Breast cancer treatment still depends on your subtype, biomarker results, prior treatment history, and how you and your oncology team weigh potential benefits against side effects.
If you have questions or concerns about your current treatment plan, talk with your oncologist or another member of your cancer care team. They can help you understand whether biomarker testing, a treatment change, or a conversation about side effect management makes sense for you.
On MyBCTeam, people share their experiences with breast cancer, get advice, and find support from others who understand.
Have you spoken with your healthcare provider about new treatment options? Let others know in the comments below.
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