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European Commission Approves Roche's Alecensa For ALK-positive Early-stage Lung Cancer

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
rttnewslogo20mar2024

Roche (RHHBY) said that the European Commission has approved Alecensa (alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with anaplastic lymphoma kinase or ALK-positive non-small cell lung cancer or NSCLC at high risk of recurrence.

The company noted that data from the Phase III ALINA trial, where Alecensa demonstrated an unprecedented 76% reduction in the risk of disease recurrence or death in people with resected ALK-positive NSCLC, supported the marketing authorisation application.

Today's approval in Europe follows the April 2024 U.S. Food and Drug Administration (FDA) approval of Alecensa as adjuvant treatment following tumour resection for patients with ALK-positive NSCLC (tumours greater that or equal to 4 cm or node positive), as detected by an FDA-approved test.

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