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Roche’s Alecensa (Alectinib) Receives the EC’s Approval as an Adjuvant Treatment for Early-Stage Lung Cancer

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Roche’s Alecensa (Alectinib) Receives the EC’s Approval as an Adjuvant Treatment for Early-Stage Lung Cancer

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  • 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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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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