Human medicines European public assessment report (EPAR): Retsevmo, selpercatinib, Date of authorisation: 11/02/2021, Revision: 21, Status: Authorised

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Retsevmo is a cancer medicine for use in patients whose cancer is caused by certain changes in a gene called RET, leading to the production of abnormal RET proteins. It can be used for: Retsevmo contains the active substance selpercatinib. advanced non-small cell lung cancer (NSCLC) in adults not previously treated with a RET inhibitor;

advanced thyroid cancer in patients from 2 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 from 2 years of age;

advanced solid tumours in patients from 2 years of age in whom treatments not targeting the RET protein have not worked well enough or who have no other treatment option. English (EN) (162.5 KB – PDF) English (EN) (1.11 MB – PDF) Retsevmo: EPAR – Medicine overview Retsevmo: EPAR – Risk management plan 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 and tablets to be taken by mouth two or three times a day. The daily dose depends on the patient’s age and body weight. 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 that 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). In adults with NSCLC 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. Solid tumours (other than NSCLC and thyroid cancer) Retsevmo was tested in 52 adults with a solid tumour (mostly cancer of the pancreas or the colon, and 14 other types of cancer), the majority of whom had been treated before but none of whom had previously received a RET inhibitor. The results showed that around 44% of patients (23 out of 52) had a complete or partial response to treatment, which lasted on average 37 months. 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. Additional study in children from 2 years of age An additional study was carried out in children from 2 years of age. In this study, which involved 36 children with thyroid cancers or solid tumours with abnormalities in the RET gene, 53% responded to treatment with Retsevmo. Studies carried out with Retsevmo are described in more detail in the medicine’s assessment reports. 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), hypersensitivity (allergic reactions), abdominal (belly) pain, low levels of sodium in the blood, diarrhoea, vomiting, fever, bleeding, blood tests showing changes in liver enzymes (indicating stress on the liver), increased creatinine (indicating kidney problems) and urinary tract infections. Retsevmo has been found to be effective at treating NSCLC and certain thyroid cancers caused by changes in the RET gene, reducing the size of the cancer in most patients. Beneficial effects were also shown in patients with other solid tumours that have changes in the RET gene. Its side effects are considered manageable. 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 was originally given ‘conditional authorisation’ and the company was required to provide more evidence about the medicine. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to standard authorisation.