Trodelvy (sacituzumab govitecan-hziy)
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Trodelvy (sacituzumab govitecan-hziy) is a medication used for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease and for patients with locally advanced or metastatic urothelial cancer (UC).
Disease Indications
Urothelial Carcinoma, Breast Cancer
Manufacturer
Immunomedics Inc.
Usage
Intravenous
Medicine approved by
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Food and Drug Administration (FDA)
Patients helped
- Over 2 million patients reached
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- 100% successful deliveries to 87 countries
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Package
Single-dose vial
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Daniela Figueira, PharmaD
Patient Support Agent
What is Trodelvy (sacituzumab govitecan-hziy) for?
Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate (ADC) indicated for patients with:1
- Previously-treated metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
- Locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.
It is available in vial form each containing 180 mg of sacituzumab govitecan-hziy.1
How does Trodelvy (sacituzumab govitecan-hziy) work?
The active ingredient in Trodelvy, sacituzumab govitecan-hziy, is an antibody-drug conjugate (ADC), which belongs to a new class of biological drugs. It targets the protein Trop-2, which is found in high levels in more than 90% of triple-negative breast cancers. Sacituzumab govitecan-hziy is made up of 3 parts:2
- Sacituzumab, a Trop-2-recognizing antibody, which is a type of protein designed to recognise and attach to the Trop2 antigen present on cancer cells.
- SN-38, a topoisomerase I inhibitor (chemotherapy), which damages the tumor cell’s DNA and inhibits further DNA replication.
- A compound that conjugates (links) these two parts together.
When sacituzumab binds to Trop-2 on the cancer cell, the drug is taken up by the cell and the linker is broken subsequently, releasing SN-38. SN-38 then causes the destruction of Trop-2-positive cancer cells.1,2
Where has Trodelvy (sacituzumab govitecan-hziy) been approved?
Trodelvy (sacituzumab govitecan-hziy) was approved with accelerated approval by the Food and Drug Administration (FDA), USA:
- On April 22, 2020 for the treatment of patients with previously-treated mTNBC.2
- On April 13, 2021 for the treatment of advanced bladder cancer.6,8
Trodelvy has not yet been approved by the European Medicines Agency (EMA). On March 25, 2021 the EMA announced that it has validated the marketing authorization application (MAA) for Trodelvy. The application is now under accelerated review by the EMA.7
The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designation, to aid in the development of therapies to treat serious conditions and to fill an unmet medical need.2
Trodelvy (sacituzumab govitecan-hziy) for other indications
In October 2020, Trodelvy also received orphan drug designation for the treatment of adult and pediatric patients with glioblastoma, an aggressive type of brain cancer.4
Trodelvy is also being developed as an experimental treatment for HR-positive, HER2-negative breast cancer and metastatic non-small cell lung cancer.8
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India concerning the quality of their medicines.
How is Trodelvy (sacituzumab govitecan-hziy) taken?
The standard dosage is:1
- 10 mg/kg body weight given into the vein (intravenous infusion)
This dosage is given once per week on days 1 and 8 of 21-day treatment cycles. The first infusion is administered over 3 hours. If the initial infusion is well tolerated, subsequent infusions can be administered over 1 to 2 hours. Treatment should be given until disease progression or unacceptable toxicity.1
Complete information about Trodelvy (sacituzumab govitecan-hziy) dosage and administration can be found in the official prescribing information listed in our references section.1
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Trodelvy (sacituzumab govitecan-hziy)?
Common adverse reactions
The most common adverse reactions (>25% of patients) listed in the prescribing information include:1
- Nausea
- Diarrhea
- Fatigue
- Anemia
- Vomiting
- Alopecia
- Constipation
- Rash
- Decreased appetite
- Abdominal pain
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- Low white blood cell count (neutropenia)
- Anemia
- Hypophosphatemia
- Severe diarrhea
Use in specific populations
Trodelvy (sacituzumab govitecan-hziy) can be fatal for a foetus, it is advised to avoid pregnancies and breastfeeding.1
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
1. Full prescribing information [FDA]: Trodelvy (sacituzumab govitecan-hziy) [PDF]
Immunomedics, Inc.
2. FDA Approves New Therapy for Triple Negative Breast Cancer
FDA press release, April 22, 2020
3. FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer
Drugs News, April 22, 2020
4. Immunomedics Announces FDA Orphan Drug Designation of Trodelvy™ for Adult and Pediatric Glioblastoma
Immunomedics press release, Oct 12, 2020
5. ESMO 2020: Immunomedics presents new Trodelvy data in two indications
The Pharmaletter, Sept 21, 2020
6. Immunomedics Announces Positive Results from Pivotal Phase 2 TROPHY U-01 Study of Trodelvy™ in Metastatic Urothelial Cancer
Immunomedics, Sept 19, 2020
7. European Medicines Agency Validates Marketing Authorization Application for Sacituzumab Govitecan-Hziy for the Treatment of Metastatic Triple-Negative Breast Cancer
Gilead, Mar 2021
8. U.S. FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer
Gilead, Apr 2021
For more information please visit our blog page "What is Trodelvy?"
Metastastic Triple-Negative Breast Cancer (mTNBC)
The Food and Drug Administration (FDA), USA, approval of sacituzumab govitecan-hziy (Trodelvy) in patients with previously-treated metastatic triple-negative breast cancer (mTNBC) was based on data from the study ASCENT (IMMU-132-01; ).1,2
IMMU-132-01 was a single-arm, open-label phase 1/2 clinical trial that involved 108 people diagnosed with metastatic triple-negative breast cancer that had been previously treated with chemotherapy. Trodelvy was administered on days 1 and 8 of 21-day treatment cycles, until unacceptable toxicity or progression of disease.2
Results
Among the efficacy outcome measures were overall response rate (ORR), which is defined as the proportion of patients who have a partial or complete response to therapy, and duration of response (DOR), which is the time between the initial response to therapy and subsequent disease progression or relapse.2
Trodelvy Improved overall survival in previously treated mTNBC patients.3
Study results showed that ORR in patients treated with Trodelvy (sacituzumab govitecan-hziy) was 33.3% [95% CI 24.6, 43.1]. 2.8% of patients had a complete response, and 30.6% had a partial response.3
The median DOR of responders (n=36) was 7.7 [95% CI 4.9, 10.8], with 55.6% of patients having a duration of ≥ 6 months, and 16.7% of patients with duration ≥ 12 months.3
Urothelial Carcinoma (UC)
The Food and Drug Administration (FDA), USA, approval of sacituzumab govitecan-hziy (Trodelvy) in patients with with locally advanced or metastatic urothelial cancer was based on data from the study TROPHY-UO1 (also known as IMMU-132-06; NCT03547973).4
TROPHY is an ongoing, international, multi-center, open-label, phase II study that involves 112 patients with metastatic urothelial cancer who have tried two prior therapies, including a platinum-based chemo and a PD-1/L1 checkpoint inhibitor. In cohorts 1 and 2, patients received sacituzumab govitecan 10 mg/kg body weight intravenously on days 1 and 8 of a 21-day cycle. Treatment continued until disease progression or loss of clinical benefit.4
Results
The main efficacy outcomes were overall response rate (ORR), which is defined as the proportion of patients who have a partial or complete response to therapy, and duration of response (DOR), which is the time between the initial response to therapy and subsequent disease progression or relapse.4
27.7% of those treated with Trodelvy (sacituzumab govitecan-hziy) responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The median DOR was 7.2 months [95% CI: 4.7, 8.6].3
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Trodelvy (sacituzumab govitecan-hziy) for the approved indication.5
References
1. FDA Approves New Therapy for Triple Negative Breast Cancer
FDA press release, April 22, 2020
2. ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer
Clinical Trial ASCENT, cited Jul 2020
3. U.S. FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer
Gilead, Apr 2021
4. Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer
Clinical Trial TROPHY, cited Apr 2021
5. Full prescribing information [FDA]: Trodelvy (sacituzumab govitecan-hziy) [PDF]
Immunomedics, Inc.
Trodelvy (sacituzumab govitecan-hziy) treatment costs
The cost for a monthly or yearly treatment of Trodelvy (sacituzumab govitecan-hziy) depends on your prescription requirements which includes the dosage in mg and medicine type (Single-dose vial).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Trodelvy (sacituzumab govitecan-hziy) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Trodelvy (sacituzumab govitecan-hziy) price and additional costs
The price of Trodelvy (sacituzumab govitecan-hziy)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
Our Named Patient support fee
TheSocialMedwork provides access to Trodelvy (sacituzumab govitecan-hziy) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
Shipping costs
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
You can read a detailed overview of prices and costs here.
Payment methods when you buy Trodelvy (sacituzumab govitecan-hziy)
When you buy Trodelvy (sacituzumab govitecan-hziy), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Trodelvy (sacituzumab govitecan-hziy) reimbursement
It might be possible for you to claim the cost of Trodelvy (sacituzumab govitecan-hziy) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping. For more details, please see our article on cold chain delivery.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Four steps to access the medicines you need
How and where to buy Trodelvy: You can order Trodelvy from TheSocialMedwork if the drug has not been approved or is not available in your country.
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Step 1
You send a request for your medicine online
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
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Step 2
We verify your prescription and medical details
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
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Step 3
We source your medicine
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
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Step 4
We deliver your medicine
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
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Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.
