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EMA Recommends Extension of Therapeutic Indications for Selpercatinib

It adopted an extension of indication for the treatment of advanced RET-mutated medullary thyroid cancer
25 Aug 2022
Anticancer agents & Biologic therapy;  Cancer in Special Situations / Population;  Endocrine and neuroendocrine tumours;  Personalised medicine

On 21 July 2022, the European Medicines Agency’s (EMA’s) 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 selpercatinib (Retsevmo).

The marketing authorisation holder for this medicinal product is Eli Lilly Nederland B.V.

The CHMP adopted an extension of indication for the treatment of advanced RET-mutated medullary thyroid cancer.

For information, the full indication will therefore be 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
  • advanced RET fusion positive thyroid cancer who require systemic therapy following prior treatment with sorafenib and/or lenvatinib.

Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutated medullary thyroid cancer (MTC).

The last indication is changed as previous one concerned the treatment of adults and adolescents 12 years and older with advanced RET-mutated MTC who required systemic therapy following prior treatment with cabozantinib and/or vandetanib.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report 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.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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