A New FDA Approval for Advanced Breast Cancer
- Metastatic breast cancer patients urgently need more options. The Food and Drug Administration’s recent approval of Datroway represents a step forward in giving patients another tool to fight this disease.
- Datroway is what’s known as an antibody drug conjugate. It’s the third drug of this sort to be approved for HR-positive/HER2-negative metastatic breast cancer.
- Antibody drug conjugates give more payload to cancer cells compared to normal cells, so patients have improved survival, as well as better quality of life.
- “It’s a way of selectively targeting or tagging the cancer cells and killing the cancer cells while sparing the normal cells,” Dr. Aditya Bardia, an oncologist at UCLA Health Jonsson Comprehensive Cancer Center, tells SurvivorNet.
The Food and Drug Administration (FDA) recently approved datopotamab deruxtecan (brand name Datroway), a promising new option known as an antibody drug conjugate.
Read MoreThis is an exciting development for women with advanced breast cancer — a population that needs more good treatment options.
Understanding Breast Cancer Types
This drug approval is for women with a specific type of advanced breast cancer. Here’s a breakdown of what that means:
- HR-Positive: Breast cancer cells that have receptors for either estrogen or progesterone — or both — are considered hormone receptor positive. These hormones can help fuel the growth of cancer cells.
- HER2-Negative: This refers to cancer cells that do not over-express the HER2 protein.
- Metastatic: This refers to cancer that has spread beyond the breast to other parts of the body, such as bones, lungs, liver, or brain.
HR-positive/HER2-negative breast cancer remains the most common subtype of breast cancer. While endocrine (hormone) therapies are typically used early on, they may become less effective over time, requiring a switch to chemotherapy or other treatments.
What Is Datroway (Datopotamab Deruxtecan)?
Datroway (also referred to as datopotamab deruxtecan or Dato-DXd) is a Trop2-directed antibody-drug conjugate (ADC). In other words, it’s a targeted therapy designed to deliver a potent cancer-fighting medication directly into cancer cells that express the Trop2 protein. By focusing the drug where it’s most needed, Datroway aims to limit cancer growth while reducing harm to healthy tissues.
“Antibody drug conjugates essentially are replacing chemotherapy. So wherever chemotherapy is used in the field of breast oncology, oncology in general, antibody drug conjugates are replacing them. So patients with metastatic breast cancer when they’re candidates for chemo, that’s where one should think about antibody drug conjugates based on the approvals,” says Dr. Bardia.
In the TROPION-Breast01 clinical trial, Datroway was compared head-to-head with commonly used chemotherapies like eribulin, capecitabine, vinorelbine, or gemcitabine. This study involved patients whose cancer had progressed after endocrine therapy and at least one previous chemotherapy.
Results from the trial indicate:
- Improved Progression-Free Survival (PFS)
- Median progression-free survival is the amount of time that half of the people enrolled in the trial were on treatment before their cancer started growing or spreading.
- Patients treated with Datroway had a median PFS of 7 months, compared with 5 months for those on standard chemotherapy.
- Overall response rate (tumor shrinking) results
- This is the proportion of people who have a partial or complete response to therapy.
- 36% of people had their tumors shrink with Datroway, compared to 23% of people for those who received standard chemotherapy
While Datroway showed clear benefits in delaying cancer progression, the median overall survival (time until death from any cause) was not significantly different compared to chemotherapy in this trial period.
Median overall survival was 18.6 months with Datroway versus 18.3 months with chemotherapy.
Dr. Bardia explains that doctors consider antibody drug conjugates like “smart bombs or smart missiles.”
“The antibody binds to a cancer cell and then selectively delivers the payload differentially to cancer cells,” she says. “So it’s a way of selectively targeting or tagging the cancer cells and killing the cancer cells while sparing the normal cells.”
When Should Datroway Be Used
“This is the third antibody drug conjugate that’s approved in this setting,” Dr. Bardia explains.
“We usually use hormonal based therapy, often we then use capecitabine [chemotherapy] and then after capecitabine, we consider Trastuzumab Deruxtecan, Sacituzumab Govitecan and this would be the third option to consider. A question for the field is which one to start with?”
The three FDA approved antibody drug conjugates are:
- Datopotamab Deruxtecan (brand name Datroway)
- Sacituzumab Govitecan (brand name Trodelvy)
- Trastuzumab Deruxtecan (brand name Enhertu)
“The whole idea with antibody drug conjugates, is that they give more payload to cancer cells as compared to normal cells. So you have not only improvement in survival, but also better quality of life,” Dr. Bardia adds.
Potential Side Effects
Like all medications, Datroway can cause side effects.
In clinical studies, the most commonly reported reactions included:
- Stomatitis (mouth sores)
- Nausea and vomiting
- Fatigue
- Low blood cell counts (e.g., leukocytes, neutrophils, lymphocytes)
- Changes in liver enzymes (ALT, AST)
- Hair loss (alopecia)
- Eye-related symptoms (dry eye, keratitis)
If you or a loved one starts this treatment, it’s important to report any side effects to your healthcare team right away. Early intervention can make a big difference in how well side effects are managed.
Recommended Dose and Administration
The approved dose for Datroway is 6 mg/kg given by intravenous (IV) infusion once every 3 weeks. Treatment continues until the cancer worsens or side effects become unmanageable.
“Datopotamab deruxtecan is given through an IV every three weeks. This is different from another drug (Trodelvy) which is given on day one and day eight of a 21-day cycle,” Dr. Bardia explains. “The difference in schedules doesn’t affect the side effects but does affect how often patients need to visit the infusion center. This is something we discuss with each patient to see what fits best with their schedule and preferences.”
Your oncology team will monitor you closely through blood tests, imaging, and side effect assessments to ensure safety and effectiveness.
Questions to Ask Your Doctor
- Am I eligible to receive Datroway?
- Why do you think Datroway is the right option for me at this point in my treatment?
- Is the safety and tolerability of Datroway acceptable for long-term use?
- What are the most common side effects, and how can we manage them?
- How often and for how long will I need to take Datroway?
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