Datroway is a treatment for certain types of breast cancer that are hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative.
How Does Datroway Work for Breast Cancer?
Datroway is a type of medicine known as an antibody drug conjugate (ADC). The ADC is designed to deliver medicine directly to the cancer cells and is made up of three parts.
- An antibody that targets and attaches to a specific protein on a cancer cell.
- A type of chemotherapy to kill the cancer cells.
- A linker (or conjugate) that attaches the antibody to the chemotherapy. This keeps the antibody and chemotherapy together in the blood but then allows them to separate in the tumor cells.
When Datroway attaches to the protein known as Trop-2 on cancer cells, the chemotherapy is released, which causes the cancer cell to die.
How Do I Use Datroway for Breast Cancer?
Datroway is an intravenous (IV) infusion given through a blood vessel in your arm by your health care provider. Your dose will depend on your body weight. You will receive a Datroway infusion every three weeks at an infusion center, hospital, or clinic. Your health care provider will determine how many treatments you will receive.
On the day of your infusion, your health care provider will give you medicines before your infusion to help prevent nausea, vomiting, and infusion reactions. Your first infusion of Datroway will be given over 90 minutes. Your remaining infusions of Datroway may be given over 30 minutes if you did not have any side effects during your first treatment.
You will be monitored for at least one hour after your first two infusions. Then you may be monitored for at least 30 minutes for all other infusions if you do not have any problems during the first two infusions.
Is Datroway Right for Me?
Your health care provider may consider treatment with Datroway if you have breast cancer that is:
- Hormone receptor-positive and HER2-negative
- Unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body)
You must have also received hormone treatment (endocrine-based therapy) and chemotherapy to be considered for Datroway treatment.
How Was Datroway Studied for Breast Cancer?
The TROPION-Breast01 study is an international clinical trial that looked at how well Datroway worked for people with certain types of unresectable or metastatic breast cancer. The study included 732 people. Of them, 365 people were treated with Datroway and 367 people were treated with chemotherapy that was chosen by their health care provider.
People in the study were 28 to 86 years old. About 40% of people in the study were Asian, 48% were White, 1.5% were Black or African American, and the remainder did not report race or were categorized as “other.” Most of the people in the study had metastatic disease (98.5%).
The researchers evaluated the effectiveness of Datroway for breast cancer by looking at:
- The overall response rate, which is the percentage of people who had cancer that shrank by 30% (known as a partial response) or could no longer be detected (known as a complete response).
- The median (middle) progression-free survival, which is the amount of time that half of the people in the trial were on treatment before their cancer started growing or spreading.
- The median (middle) overall survival, which is the amount of time that half of the people in the trial lived since starting treatment.
What Benefits of Datroway Were Seen in the Studies for People With Breast Cancer?
- The overall response rate was 36.4% (35.9% partial response and 0.5% complete response) in people treated with Datroway. The overall response rate was 22.9% (22.9% partial response and 0% complete response) in people treated with chemotherapy.
- The median time for progression-free survival was 6.9 months in people treated with Datroway compared with 4.9 months for people treated with chemotherapy.
- The median time for overall survival was similar for people treated with Datroway (18.6 months) and chemotherapy (18.3 months).
Your results may differ from what was seen in clinical studies.
What Can I Do to Prevent Side Effects With Datroway?
Side effects may be common with medicines like Datroway. Not all side effects can be prevented, but there are things you can do to help.
- Eye problems are common with Datroway treatment. These side effects may be severe. You should use lubricating eye drops at least four times each day and as needed to help prevent side effects. Do not wear contact lenses during treatment with Datroway unless your health care provider tells you to. Tell your health care provider right away if you notice any new or worsening eye problems including dry eyes, eye pain, eye redness, eye swelling, eye irritation, increased tears, feeling like something is in your eyes, discharge from your eyes, eye crusting, sensitivity to light, vision changes, or blurred vision. Your health care provider will recommend an eye specialist to monitor your eye health while you receive Datroway treatment.
- Mouth sores are common with Datroway treatment. These side effects may be severe. You can help prevent mouth sores by holding ice chips or ice water in your mouth during your Datroway infusions. Your health care provider will prescribe a mouthwash that should be used four times each day and as needed. Tell your health care provider right away if you notice any new or worsening mouth sores.
- Nausea and vomiting are possible side effects of Datroway treatment. You should take nausea medicine as prescribed by your health care provider.
Your health care provider may decrease your dose, delay treatment, or stop treatment if you have severe side effects during Datroway treatment.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088).
What Are Other Unique Considerations to Be Aware of During Datroway Treatment?
Datroway can cause serious lung problems known as interstitial lung disease or pneumonitis. Tell your health care provider right away if you have a cough, trouble breathing, shortness of breath, fever, or other breathing problems such as chest tightness or wheezing. Your health care provider may treat you with corticosteroid medicines if you develop lung problems.
Datroway may cause harm to your unborn baby. Your health care provider will do a pregnancy test before starting Datroway treatment if you are able to become pregnant. If you are able to become pregnant, you should use effective birth control during treatment and for seven months after the last dose. Males who have partners who are able to become pregnant should use effective birth control during treatment and for four months after the last dose.
Is There Any Cost Assistance Available?
You can find a savings card from the drugmaker of Datroway. The savings card may allow you to pay as little as $0 for your prescription. You may be eligible for this savings coupon if you have private drug insurance. There are also cost assistance programs available if you do not have private drug insurance. You can read more about the savings coupon and other cost assistance programs at this website.
