Alunbrig

brigatinib

Table of contents

Opinion

On 27 February 2020, 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 Alunbrig. The marketing authorisation holder for this medicinal product is Takeda Pharma A/S.

The CHMP adopted a new indication as follows:

“Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.”

For information, the full indications for Alunbrig will be as follows*:

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.

Alunbrig is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.”

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.


*New text in bold, removed text as strikethrough

Key facts

Name
Alunbrig
Agency product number
EMEA/H/C/004248
International non-proprietary name (INN) or common name
  • brigatinib
Active substance
  • brigatinib
Therapeutic area
Carcinoma, Non-Small-Cell Lung
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.

Date opinion adopted
27/02/2020
Company name
Takeda Pharma A/S
Status
Positive
Application type
Post-authorisation

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