Gavreto (pralsetinib)
We can help with your prescription. Read the “Prescription Guide”.
You can access this medicine even if it's not approved in your country. Learn how.
Disease Indications
Lung Cancer, Thyroid Cancer
Manufacturer
Roche Registration Limited
Usage
Oral
Medicine approved by
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European Medical Agency (EMA)
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Food and Drug Administration (FDA)
Patients helped
- Over 1.2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 88 countries
We can help with your import documents
We are experts in import regulations. Scroll below to download the import guide for your country.
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]
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- +31 20 808 4414 (EU)
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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
Gavreto (pralsetinib)
Package
Capsules
Where can we deliver?
We have delivered medicines to more than 88 countries. Check if we have sent medicines to yours.
We currently can’t ship medicines to - contact us for alternative options.
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PICK-UP IN PERSON FROM A PARTNER PHARMACY
We can arrange for you to pick up this medicine from our partner pharmacy in Luxembourg. Read more.
Pick-up from Luxembourg.
Depending on your particular circumstance, this option can be cheaper and require less paperwork than direct delivery. You can ask someone else to pick up the medicine on your behalf.
In some cases, medicines can be picked up from partner pharmacies in Amsterdam (the Netherlands) or Dusseldorf (Germany).
Tell our Patient Support Team if you’re interested in pick-up options for your order.
Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
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SELF-PACED MASTERCLASSYou have more treatment options than you think.
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What is Gavreto (pralsetinib) for?
Gavreto (pralsetinib) is a kinase inhibitor (chemotherapy) indicated for the treatment of adult patients with:
- RET fusion-positive non-small cell lung cancer (NSCLC) that has spread (metastasized)1
- Advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)5
It is available in capsule form containing 100 mg Gavreto (pralsetinib).1
How does Gavreto (pralsetinib) work?
Pralsetinib is a kinase inhibitor. Kinase inhibitors can block a type of enzyme called kinase. Pralsetinib targets the tyrosine kinase REarranged during Transfection (RET). RET is present on the surface of various cell types, including lung and thyroid cells.2
In several types of cancers the RET gene is fused or rearranged. The RET gene can combine with a different gene to form a fusion gene. This fusion gene activates the RET enzyme, which then always sends growth signals to the cell. This leads to the development of cancer.3
When taken, pralsetinib can bind to and target RET, which leads to the death of tumor cells and prevention of cancer growth.1
Where has Gavreto (pralsetinib) been approved?
Gavreto (pralsetinib) was approved by:
- The Food and Drug Administration (FDA), USA, for the treatment of patients with:
- Metastatic RET fusion-positive NSCLC on September 4, 2020.4
- RET-altered thyroid cancers on November 30, 2020.5
- The European Medicines Agency (EMA):
- For first-line treatment of people with RET fusion-positive advanced NSCLC.6
The FDA granted Breakthrough Therapy designation to Gavreto for the treatment of advanced RET fusion-positive NSCLC and for RET mutation-positive medullary thyroid cancer (MTC). The FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid 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 Gavreto (pralsetinib) taken?
The standard dosage is:1
- 400 mg taken by mouth (orally) once daily on an empty stomach (do not eat for at least 2 hours before and at least 1 hour after taking Gavreto).
Patients will be selected for treatment with Gavreto based on the presence of RET gene fusion or a specific RET gene mutation in tumor biopsies or blood.1
Dosage is modified when Gavreto is given together with strong CYP3A inducers or with combined P-glycoprotein and strong CYP3A inhibitors, or in case of the occurrence of adverse reactions.1
Complete information about Gavreto (pralsetinib) 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 Gavreto (pralsetinib)?
Common adverse reactions
The most common adverse reactions (≥20% of patients) listed in the prescribing information include:1
- Tiredness (fatigue)
- Constipation
- Muscle and joint pain
- High blood pressure
- Decreased white blood cell and red blood cell counts
- Decreased levels of phosphate in the blood
- Decreased levels of body salt (sodium) in the blood
- Decreased levels of calcium in the blood
- Abnormal liver function blood tests
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:1
- Inflammation of the lungs
- Liver problems (increased liver function blood test results)
- High blood pressure (hypertension)
- Bleedings (hemorrhage)
- Risk of wound healing problems
Use in a specific population
Gavreto (pralsetinib) can cause fetal harm when administered to a pregnant woman; it is advised to avoid pregnancies and breastfeeding.1
Gavreto may affect fertility in men and women, which may affect your ability to have children. Talk to your doctor if this is a concern for you.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]: Gavreto (pralsetinib) [PDF]
Roche, Sept 2020
2. RET fusion in advanced non-small-cell lung cancer and response to cabozantinib
Wang Y, Medicine (Baltimore), Jan 18, 2019
3. The Role of RET Rearrangements in Lung Cancer
Cure Today article, Aug 26, 2020
4. Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer
Roche press release, Sep 7, 2020
5. Blueprint Medicines Announces FDA Approval of GAVRETO™ (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancer
Biospace news item, Dec 1, 2020
6. Gavreto wins conditional EU approval to treat form of lung cancer -Roche
Reuters.com, Nov 2021
The Food and Drug Administration (FDA), USA, approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) was based on the data of study ARROW (NCT03037385).1
ARROW was a multicenter, non-randomized, open-label, multi-cohort phase 1/2 study to investigate the safety, tolerability and efficacy of Gavreto (pralsetinib). The study involved 87 patients with RET fusion-positive NSCLC who had not been treated before with other therapies (treatment-naive), or were pretreated with platinum chemotherapy.2
The study consisted of two parts: a dose escalation phase, and an expansion phase in which people were treated with 400 mg of Gavreto, once-daily.2
Results
The main efficacy outcome was overall response rate (ORR), which is defined as the percentage of patients experiencing partial or complete shrinkage of their tumors. Additionally, duration of response (DOR) was measured to evaluate how long that shrinkage lasted.2
Gavreto had a beneficial clinical effect on people with RET fusion-positive NSCLC with or without prior therapy.3
ORR was:3
- 57% [95% CI: 46, 68] in pre-treated NSCLC patients, with 5.7% of patients having a complete response and 52% a partial response.
- 70% [95% CI: 50, 86] in treatment-naive NSCLC patients, with 11% of patients having a complete response and 59% a partial response.
DOR was:3
- Not estimable in pre-treated NSCLC patients.
- 9.0 months in treatment-naive NSCLC patients.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Gavreto (pralsetinib) for the approved indication.4
References
1. Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer
Roche press release, Sep 7, 2020
2. Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors (ARROW)
Clinical Trial ARROW (NCT03037385), last updated on Aug 24, 2020
3. Registrational dataset from the phase I/II ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET fusion+ non-small cell lung cancer (NSCLC).
Gainor JF, Journal of Clinical Oncology, May 20, 2020
4. Full prescribing information [FDA]: Gavreto (pralsetinib) [PDF]
Roche, Sept 2020
Gavreto (pralsetinib) treatment costs
The cost for a monthly or yearly treatment of Gavreto (pralsetinib) depends on your prescription requirements which includes the dosage in mg and medicine type (Capsules).
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 Gavreto (pralsetinib) 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.
Gavreto (pralsetinib) price and additional costs
The price of Gavreto (pralsetinib)
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 Gavreto (pralsetinib) 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 Gavreto (pralsetinib)
When you buy Gavreto (pralsetinib), 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.
Gavreto (pralsetinib) reimbursement
It might be possible for you to claim the cost of Gavreto (pralsetinib) 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.
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
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 Gavreto: You can access Gavreto 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.
