SOUTH SAN FRANCISCO (dpa-AFX) - 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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