Retsevmo

Retsevmo is available as capsules containing 40 or 80 mg 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.

The dose of Retsevmo is 160 mg twice daily, reduced to 120 mg twice daily in patients weighing less than 50 kg. 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 the 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 received treatment 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.

Advanced medullary thyroid cancer

In adults and adolescents aged from 15 years 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 for adults.

The most common side effects with Retsevmo (which may affect more than 1 in 10 people) are loss of appetite, headache, dizziness, prolonged QT interval (changes in the heart’s electrical activity), high blood pressure, abdominal (belly) pain, diarrhoea, nausea (feeling sick), vomiting, constipation, dry mouth, rash, fever, tiredness, oedema (swelling caused by fluid build-up), bleeding, and blood tests showing changes in liver enzymes (indicating stress on the liver), decreased platelet (components that help the blood clot) and white blood cell counts, decreased magnesium and increased creatinine (indicating kidney problems).

The most common serious side effects are abdominal pain, hypersensitivity (allergic reactions), diarrhoea and blood tests showing changes in liver enzymes.

For the full list of side effects and restrictions of Retsevmo, see the package leaflet.

Retsevmo was found to be effective at treating cancers involving changes to the RET gene, reducing the size of the cancer in most patients. Its side effects are considered manageable. The European Medicines Agency therefore decided that Retsevmo’s benefits are greater than its risks and it can be authorised for use in the EU.

Retsevmo has been given ‘conditional authorisation’. This means that although the European Medicines Agency decided that the benefits of Retsevmo are greater than its risks, 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 and this overview will be updated as necessary.

Since Retsevmo has been given conditional authorisation, the company that markets Retsevmo will provide results of studies to confirm its long-term effectiveness 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.

The overview was last updated in 11-2022.