Retsevmo

selpercatinib

Table of contents

Opinion

On 22 April 2022, 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 an extension to an existing indication as follows:1

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 inhibitorwho require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

For information, the full indication for Retsevmo 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 RETinhibitor
  • 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‑mutant medullary thyroid cancer (MTC) who require 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 (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.

1New text in bold, removed text as strikethrough

Key facts

Name
Retsevmo
Agency product number
EMEA/H/C/005375
International non-proprietary name (INN) or common name
  • selpercatinib
Active substance
  • Selpercatinib
Therapeutic area
Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms
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.

Date opinion adopted
22/04/2022
Company name
Eli Lilly Nederland B.V.
Status
Positive
Application type
Post-authorisation

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