Summary of opinion: Alecensa, 25/04/2024 Positive
On 25 April 2024, 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 Alecensa. The marketing authorisation holder for this medicinal product is Roche Registration GmbH.
The CHMP adopted a new indication as follows:
Adjuvant treatment of resected non‑small cell lung cancer (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 (see section 5.1 for selection criteria).
For information, the full indications for Alecensa will be as follows1:
Adjuvant treatment of resected non‑small cell lung cancer (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 (see section 5.1 for selection criteria).
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 (SmPC), which will be published in the revised European public assessment report (EPAR) 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.
1 New text in bold
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