On 25 April 2024, 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 alectinib (Alecensa).
The marketing authorisation holder for this medicinal product is Roche Registration GmbH.
The CHMP adopted a new indication as follows:
Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence.
For information, the full indications for Alecensa will be as follows (new indication in bold):
Adjuvant treatment of resected NSCLC
Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence.
Treatment of advanced NSCLC
- Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK-positive advanced NSCLC.
- Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
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 made 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.
