CHMP positive recommendation to extend the marketing authorisation of Alecensa (alectinib hydrochloride).- Roche.
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: i. Adjuvant treatment of resected non-small cell lung cancer (NSCLC). ii. Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with ALK-positive NSCLC at high risk of recurrence .
For information, the full indications for Alecensa will be as follows1: i. 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 . ii. Treatment of advanced NSCLC; i. Alecensa as monotherapy is indicated for the first-line treatment of adult patients with ALK- positive advanced NSCLC. ii. Alecensa as monotherapy is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.
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