Retsevmo - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

selpercatinib

Opinion

On 26 March 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Retsevmo. The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.

The CHMP adopted changes to the existing indications as follows:

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. For biomarker-based patient selection, see section 4.2.
• advanced RET fusion, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)

Retsevmo as monotherapy is indicated for the treatment of adults and adolescents paediatric patients 12 years of age and older with:

• advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate). For biomarker-based patient selection, see section 4.2.
• advanced RET-mutant medullary thyroid cancer (MTC). For biomarker-based patient selection, see section 4.2.
• advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections  4.4 and 5.1). For biomarker-based patient selection, see section 4.2.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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CHMP post-authorisation summary of positive opinion for Retsevmo (VR/0000282012)

Adopted Reference Number: EMADOC-1700519818-2992694

Key facts

• Name of medicine:
  Retsevmo
• EMA product number:
  EMEA/H/C/005375
• Active substance:
  selpercatinib
• International non-proprietary name (INN) or common name:
  selpercatinib
• Therapeutic area (MeSH):
  • Carcinoma, Non-Small-Cell Lung
  • Thyroid Neoplasms
• Anatomical therapeutical chemical (ATC) code:
  L01EX22
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Conditional approval:

  This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

• Marketing authorisation holder:
  Eli Lilly Nederland B.V.
• Date of opinion:
  26/03/2026
• Status:
  Positive