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)
HOW TO ACCESS THIS MEDICINE IN:
The United States
HOW TO ACCESS THIS MEDICINE IN:
The United States
1. It's legal
The FDA allows the import of unapproved medicines into the USA. Learn more here.
2. A number of documents are required
3. We can help
Click “Request details” and our friendly Patient Support team will help you access this medicine.
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FREQUENTLY ASKED QUESTIONS
We help you access approved medicines that are not approved or available in your country of residence.
Legal
Finances
Payment
- Your permanent residence is outside the European Union
- You take the medicines with you, unused within 90 days after purchase
- You have a full original receipt (which we provide you)
Unfortunately, we are unable to help with VAT refunds following delivery or collection from our partner pharmacies outside of the Netherlands.
- If you are residing within the European Union and you are not a company
- If you are coming to Amsterdam, Luxembourg or Dusseldorf to pick up your order
In case of pick up, you may be eligible for a VAT tax refund if you live outside the European Union.
Price
Reimbursement
- That you want to import an approved medicine from abroad
- The lack of reasonable treatment options available in your country (if you can, include a letter from a doctor confirming this) - no alternative to the treatment.
- That the medicine has already been approved in another country (state the name of the country)
- That your treating doctor states that this medicine is the best option for you (include a copy of the prescription in the letter to the healthcare insurance company)
Ordering and shipping
Ordering
- Name of the patient
- Contact details of patient(email and phone number)
- Copy of patient’s ID
- Contact details of the Doctor (name, address, email and phone number)
- Shipping address
- Copy of the doctor's prescription
Shipping: We can deliver to the patient's residence, a pharmacy, or doctor's office / hospital, but this depends on the country. If you’re not sure what the right choice is for you, please get in touch with our Patient Support Team and we can help you work out your exact requirements.
Once we have received this information, one of our Patient Support Team members will then check your prescription and contact you to follow up on your order. Please note that other documents may be needed for import, we will guide you through the ordering process.
Generally not, 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.
As part of our protocols we might reach out to your treating doctor for verification or information updates. By sending us your prescription you allow us to do so.
- Patient's name and date of birth
- Name of the medicine and dosage
- Required quantity
- Doctor's name and signature
- Doctor's registration number and/or stamp
Ideally, the prescription should be issued in English. Alternatively, a translation (unofficial is sufficient) must be provided.
Please be aware that your doctor may be contacted by one of our team members or by the processing pharmacy in order to verify the prescription.
Shipping
Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping.
For EMA approved medicines with prescriptions from within the Schengen zone, you can pick the medicines up from our partner pharmacy in Amsterdam, Luxembourg or Dusseldorf. For non-EMA approved medicines, with prescriptions from within the Schengen zone, you can pick the medicines up in our partner pharmacy in Dusseldorf. If you have requested to collect your medicines, you will receive a notification when the medicines are in the pharmacy and ready for you.
There are also options to deliver the medicines to other countries. Please get in touch with our Patient Support Team to discuss which other pick-up and delivery options may be suitable for you.
- Copy of the ID/passport of the patient
- Copy of the ID/passport of the person who is coming to pick up the medicines
- Letter signed by the patient stating that he/she authorises this person to pick up the medicines on his/her behalf
- Step 1 - Customs may need to check the package to verify its contents. In order to streamline this step, we include a letter for customs with information about the contents. Any additional questions will be answered by TheSocialMedwork as and when we are contacted by customs.
- Step 2 - In some countries, there are additional questions from the medical regulatory agencies (i.e. the FDA, EMA, etc). We provide them with all the necessary information based on the information provided by the patient, such as: the prescription, copy of ID and a letter from the treating doctor to show that the medicines are for personal use.
- Step 3 - Customs fees. In some cases, the recipient will be requested to pay taxes and duties. These should be arranged by the patient or receiver and are not covered by TheSocialMedwork unless stated otherwise.
Please be aware that the import of the medicines always requires customs clearance and active cooperation from the importing party. We will help and guide you but are dependent on your cooperation and responsiveness.
About us
- Complete the enquiry form on our Contact Us page
- Send an email: [email protected]
- Call us on:
- +31 20 808 4414 (EU)
- +1 646 381 0675 (US)
- +61 28 417 2910 (AUS)
Others
Available medicines
Medicine approval
The respective national and regional agencies, such as the Food and Drugs Administration (FDA) in the USA or the European Medical Authority (EMA) for the European Union assess these applications and make a decision on whether to approve new medicines. The review process is based on evaluation of the evidence provided by the company. Every agency uses a slightly different process.
- Phase I - performed in a small number of healthy volunteers or very sick patients with lack of treatment options, designed to study the effects of the medicine in the human body.
- Phase II - larger number of patients, designed to evaluate the safety and efficacy of the medicine and to determine if different dosages of the treatment have different effects.
- Phase III - large number of patient groups, designed to confirm the safety and efficacy of the medicine.
- Phase IV - after the medicine has received regulatory approval, designed to evaluate the long-term effects.
Updates
Trodelvy (sacituzumab govitecan-hziy)
Package
Single-dose vial
Where can we deliver?
We have delivered medicines to more than 88 countries. Check if we have sent medicines to yours.
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Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
What is Trodelvy (sacituzumab govitecan-hziy) for?
Trodelvy (sacituzumab govitecan-hziy) is a prescription medicine used for the treatment of adult patients with:
- Triple-negative breast cancer (mTNBC) that has spread to other parts of the body (metastatic) or cannot be removed by surgery, and who have received two or more prior treatments, including at least one treatment for metastatic disease.
- Bladder cancer and cancers of the urinary tract that have spread (metastatic) or cannot be removed by surgery, and who have received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine.
How effective is Trodelvy (sacituzumab govitecan-hziy) for breast cancer?
The approval of Trodelvy (sacituzumab govitecan-hziy) for breast cancer was based on a clinical study of 529 people with advanced HER2-positive breast cancer. Treatment with Trodelvy was compared with traditional chemotherapy.
According to the study results published:
- 57% decrease in the overall risk of disease getting worse.
- The average length of time that patients lived without their disease getting worse was extended to 4.8 months vs 1.7 months..
- 49% reduction in the risk of death.
- Patients taking Trodelvy lived almost 2x longer than those taking traditional chemotherapies: 11.8 months vs 6.9 months.
For more details refer to the prescribing information at the bottom of the page.
How effective is Trodelvy (sacituzumab govitecan-hziy) for bladder cancer?
The approval of Trodelvy (sacituzumab govitecan-hziy) for bladder cancer was based on a clinical study of 112 people with advanced bladder cancer and cancers of the urinary tract.
According to the study results published:
For more details refer to the prescribing information at the bottom of the page.
Which side effects can I expect with Trodelvy (sacituzumab govitecan-hziy)?
AAccording to the studies published, the main common side effects of Trodelvy (which may affect more than 1 in 4 people) are feeling tired or weak, hair loss, decreased red blood cell count, constipation, decreased appetite, rash, and stomach-area (abdominal) pain or discomfort.
Please note this is not intended to be a comprehensive guide. Consult your treating doctor and the prescribing information at the bottom of the page for full details of side effects.
How is Trodelvy (sacituzumab govitecan-hziy) taken?
Administration: Trodelvy is an intravenous (IV) infusion, doses are given once a week for 2 weeks (Day 1 and Day 8) of 21-day treatment cycles.
Dosage: 10 mg/kg body weight.
Please note this is not intended to be a treatment plan. For a personalised treatment plan, consult your doctor. For more details, you can also reference the full prescribing information at the bottom of the page.
Frequently Asked Questions about Trodelvy (sacituzumab govitecan-hziy)
How does Trodelvy (sacituzumab govitecan-hziy) work?
Trodelvy works as an antibody-drug conjugate (ADC). It targets the protein Trop-2, which is found in high levels in more than 90% of triple-negative breast cancers. Trodelvy is made up of 3 parts:
- Antibody, which is a type of protein that recognises and attaches to the Trop-2 present on cancer cells.
- Anti-cancer drug, which kills cancer cells once they are recognised.
- Linker, a compound that connects (links) the antibody to the anti-cancer drug
When the antibody finds and attaches to Trop-2 on the cancer cell, the drug is taken up by the cell and the anti-cancer drug is delivered into the cell. Trodelvy kills the cancer cells from within.
For more details about the way Trodelvy (sacituzumab govitecan-hziy) works, consult your doctor or see the prescribing information at the bottom of the page. This is not intended to be a comprehensive scientific explanation.
What are some contraindications to taking Trodelvy (sacituzumab govitecan-hziy)?
Trodelvy (sacituzumab govitecan-hziy) can interact with other drugs, which may affect effects of treatment or lead to serious adverse reactions:
- Strong CYP3A/Moderate CYP2C8 Inducers: avoid concomitant use.
- Strong or Moderate CYP2C8 Inhibitors: avoid concomitant use. Increase monitoring for Trodelvy toxicity with moderate CYP2C8 inhibitors.
- CYP3A Substrates: avoid concomitant use of Trodelvy where minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP3A substrate dosage.
- P-gp Substrates: consider reducing the dosage of P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicity.
What is the most important information you should know about Trodelvy (sacituzumab govitecan-hziy)?
Trodelvy (sacituzumab govitecan-hziy) can cause serious side effects. Pay special attention to new or worsening symptoms as they may be related to:
- Low white blood cell count (neutropenia)
- Severe diarrhea
- Allergic and infusion-related reactions
- Nausea and vomiting
Trodelvy may cause harm to your unborn baby. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Trodelvy and for at least 6 months after the last dose. Trodelvy may cause fertility problems in females, which could affect your ability to have a baby.
Males who have female partners that are able to become pregnant should use effective contraception during treatment with Trodelvy and for at least 3 months after the last dose.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
Where has Trodelvy (sacituzumab govitecan-hziy) been approved?
Trodelvy was approved by the Food and Drug Administration (FDA), USA:
- On April 22, 2020 for the treatment of patients with previously-treated mTNBC.
- On April 13, 2021 for the treatment of advanced bladder cancer.
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.
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.
Trodelvy (sacituzumab govitecan-hziy) for other indications
In October 2020, Trodelvy received orphan drug designation for the treatment of adult and pediatric patients with glioblastoma, an aggressive type of brain cancer.
Trodelvy is also being developed as an experimental treatment for HR-positive, HER2-negative breast cancer and metastatic non-small cell lung cancer.
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 access and buy Trodelvy: You can access 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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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.
