Retsevmo

RSS

selpercatinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Retsevmo is a cancer medicine for use in patients whose cancer is caused by changes in a gene called RET. It can be used for:

  • advanced non-small cell lung cancer in adults not previously treated with a RET inhibitor;
  • advanced thyroid cancer in adults who had previously been treated with the cancer medicines sorafenib or lenvatinib or both;
  • advanced medullary thyroid cancer in patients aged from 12 years.

Retsevmo contains the active substance selpercatinib.

This EPAR was last updated on 09/11/2022

Authorisation details

Product details
Name
Retsevmo
Agency 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 therapeutic chemical (ATC) code
L01EX22
Additional monitoringAdditional 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 approvalConditional 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.

Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
11/02/2021
Contact address

Eli Lilly Nederland BV
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

02/09/2022 Retsevmo - EMEA/H/C/005375 - II/0014/G

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

  • 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 systematic therapy following prior treatment

Assessment history

How useful was this page?

Add your rating
Average
1 rating
1 rating
1 rating