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.
Disease Indications
Breast Cancer
Manufacturer
Immunomedics Inc.
Usage
Intravenous
Medicine approved by
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Food and Drug Administration (FDA)
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Package
Single dose vial
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Read moreWhat is Trodelvy (sacituzumab govitecan-hziy) for?
Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor antibody-drug conjugate (ADC) for patients with previously-treated metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. It is available in vial form each containing 180 mg of sacituzumab govitecan-hziy.1
How does Trodelvy (sacituzumab govitecan-hziy) work?
Sacituzumab govitecan-hziy is a Trop-2-directed ADC. The molecule is made up of 3 parts:2
1. 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.
2. SN-38, a topoisomerase I inhibitor, which damages the tumor cell’s DNA and inhibits further DNA replication.
3. 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 cleaved 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 for the treatment of patients with previously-treated mTNBC by the Food and Drug Administration (FDA), USA, April 22, 2020, under accelerated approval.2
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 is the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC.3
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
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.
How is Trodelvy (sacituzumab govitecan-hziy) taken?
The standard dosage is:1
- 10 mg/kg administered as an intravenous infusion once per week on days 1 and 8 of 21-day treatment cycles.
Continue treatment until disease progression or unacceptable toxicity.
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.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 and potential drug interactions.
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.1
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
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.
The Food and Drug Administration (FDA), USA, approval of Trodelvy (sacituzumab govitecan-hziy) in patients with previously-treated metastatic triple-negative breast cancer (mTNBC) was based on data from the study IMMU-132-01.1,2
IMMU-132-01 was a single-arm, open-label phase 1/2 clinical trial that involved a subset of 108 patients with previously treated mTNBC. 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
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
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.
References
1. FDA Approves New Therapy for Triple Negative Breast Cancer
FDA press release, April 22, 2020
2. Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers
Clinical Trial, last updated Nov 22, 2019
3. Full prescribing information [FDA]: Trodelvy (sacituzumab govitecan-hziy) [PDF]
Immunomedics, Inc.
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.
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Disclaimer
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.
