Retsevmo
Authorised
This medicine is authorised for use in the European Union
selpercatinib
MedicineHumanAuthorised
Overview
Retsevmo is a cancer medicine for use in patients whose cancer is caused by changes in a gene called RET. It can be used for:
- advanced non-small cell lung cancer in adults not previously treated with a RET inhibitor;
- advanced thyroid cancer in patients from 12 years of age in whom radioactive iodine (an element that is taken up by the thyroid gland and leads to thyroid cell death) has not worked or has stopped working;
- advanced medullary thyroid cancer in patients aged from 12 years.
Retsevmo contains the active substance selpercatinib.
The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer treatments.
Retsevmo is available as capsules to be taken by mouth twice daily. Treatment with Retsevmo can continue until it stops working or the patient has severe side effects.
For more information about using Retsevmo, see the package leaflet or contact your doctor or pharmacist.
The active substance in Retsevmo, selpercatinib, is a RET inhibitor which belongs to a broader class of cancer medicines known as tyrosine kinase inhibitors. It blocks the activity of abnormal proteins, which are made by the body due to changes in the RET gene. In patients with such changes, these abnormal proteins can lead to uncontrolled cell growth and cancer. By blocking the proteins, selpercatinib helps to reduce the growth and spread of cancer cells.
In one main study in patients with cancers caused by abnormalities in the RET gene, Retsevmo was effective at reducing tumour size. In this study, Retsevmo was not compared with other medicines or placebo (a dummy treatment).
Advanced non-small cell lung cancer
In adults with non-small cell lung cancer who had previously been treated with platinum-based chemotherapy, the cancer shrank in 64% (67 out of 105) of patients treated with Retsevmo. In previously untreated patients, 84% (58 out of 69) had a complete (no signs of cancer) or partial (shrinkage of the tumour) response to treatment with Retsevmo.
Advanced thyroid cancer
In 19 adults with thyroid cancer who had previously been treated with sorafenib or lenvatinib or both, the cancer shrank in 79% of patients.
In 24 adults with thyroid cancer who did not receive other treatments besides radioactive iodine, the cancer shrank in around 96% (23 out of 24) of these patients.
In a study in patients from 12 to 21 years of age who had been previously treated or could not receive available treatments, the cancer shrank in 60% (6 out of 10) of patients. Based on these data and because the medicine is distributed in, and removed from, the body of these patients in the same way as in adults, Retsevmo is expected to be effective in adolescents.
Advanced medullary thyroid cancer
In adults and adolescents from 15 years of age with medullary thyroid cancer, the cancer shrank in 73.5% (111 out of 151) of patients who had previously been treated with cabozantinib or vandetanib, and in 81% (115 out of 142) of patients who had not previously received treatment with cabozantinib or vandetanib.
Retsevmo is also expected to be effective in adolescents from 12 years of age with medullary thyroid cancer because the medicine is distributed in, and removed from, the body of these patients in the same way as in adults.
For the full list of side effects and restrictions with Retsevmo, see the package leaflet.
The most common serious side effects with Retsevmo (which may affect up to 1 in 10 people) include pneumonia (infection of the lung), headache, hypersensitivity (allergic reactions), high blood pressure, abdominal (belly) pain, diarrhoea, nausea (feeling sick), vomiting, fever, tiredness, bleeding, blood tests showing changes in liver enzymes (indicating stress on the liver), increased creatinine (indicating kidney problems) and chylothorax (a condition in which fluid leaks into the space between lungs and the chest wall).
The European Medicines Agency decided that Retsevmo’s benefits are greater than its risks and it can be authorised for use in the EU.
Retsevmo is effective at treating non-small cell lung cancer and certain thyroid cancers caused by changes to the RET gene, reducing the size of the cancer in most patients. Its side effects are considered manageable. At the time of the medicine’s approval for these conditions, treatment options were limited and Retsevmo addressed an medical need for these patients.
There are uncertainties concerning the long-term safety and effectiveness of Retsevmo due to a lack of comparator treatment and a small number of patients included in the studies. However, these will be addressed by studies conducted by the company that markets Retsevmo.
Retsevmo has been given ‘conditional authorisation’. This means that the European Medicines Agency decided that the benefits of Retsevmo are greater than its risks, but the company will have to provide additional evidence after authorisation. Conditional authorisation is granted on the basis of less comprehensive data than are normally required. It is granted for medicines that fulfil an unmet medical need to treat serious diseases and when the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. Every year, the Agency will review any new information that becomes available until data become comprehensive and this overview will be updated as necessary.
Since Retsevmo has been given conditional authorisation, at the time of approval the company marketing Retsevmo was required to provide results of studies to confirm its long-term efficacy and safety, particularly in comparison with other medicines that are used for the cancers for which Retsevmo has been authorised.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Retsevmo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Retsevmo are continuously monitored. Side effects reported with Retsevmo are carefully evaluated and any necessary action taken to protect patients.
Retsevmo received a conditional marketing authorisation valid throughout the EU on 11 February 2021.
Product information
Latest procedure affecting product information: II/0021
29/02/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Retsevmo
- Active substance
- Selpercatinib
- International non-proprietary name (INN) or common name
- selpercatinib
- Therapeutic area (MeSH)
- Carcinoma, Non-Small-Cell Lung
- Thyroid Neoplasms
- Anatomical therapeutic chemical (ATC) code
- L01EX22
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Retsevmo as monotherapy is indicated for the treatment of adults with:
- advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with:
- advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate)
- advanced RET-mutant medullary thyroid cancer (MTC)
News on Retsevmo
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