Following the US FDA’s approval in Apr 2024, Roche’s Alecensa has received the EC’s approval to treat ALK+ NSCLC adults who are at high risk of recurrence (Stage IB [≥4 cm]–IIIA NSCLC) along with other global submissions as Adjuvant Tx.
Approval was based on a P-III (ALINA) trial assessing the safety & efficacy of adj. Alecensa vs Pt-CT to treat adults (n=257) with resected Stage IB (tumor ≥ 4 cm) to IIIA ALK+ NSCLC
Results showed a 76% reduction in the disease recurrence or death risk and the exploratory analysis showed an improved CNS, DFS with a consistent safety profile with no new safety concerns. These results were highlighted at the NEJM in Apr 2024
Ref: Roche | Image: Roche
Related News:- Roche Reports P-III Study (ALINA) Results of Alecensa (alectinib) for ALK-Positive Early-Stage Lung Cancer
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