Not real patients

FOR HEALTHCARE PROFESSIONALS

This is a global information resource. It is intended for healthcare professionals outside of the United States of America who are interested in information about ALECENSA. If you are a United States of America healthcare professional please click hereopens in a new tab.

The European Medicines Agency has approved ALECENSA monotherapy as:1

  • Adjuvant treatment following complete tumour resection for adult patients with ALK+ NSCLC at high risk of recurrence
  • First-line treatment of adult patients with ALK+ advanced NSCLC
  • Treatment of adult patients with ALK+ advanced NSCLC previously treated with crizotinib

The registration status and approved product label of ALECENSA may not be the same in different countries. This website is not country-specific and therefore may contain information which is not applicable to your country. Please refer to your local Summary of Product Characteristics for full details.

This website has been updated according to the latest European Medicines Agency approval in June 2024.

ALK: anaplastic lymphoma kinase; NSCLC: non-small cell lung cancer. 
1. Roche. ALECENSA (alectinib) Summary of Product Characteristics. 2024. Available hereopens in a new tab (accessed July 2024).
© 2024 F. Hoffmann-La Roche Ltd. M-XX-00018108; Date of preparation: July 2024

NSCLC AND

BIOMARKER TESTING

ALK+ NSCLC IS A UNIQUE SUBSET OF LUNG CANCER


WITH A DISTINCT PATHOLOGY AND CHARACTERISTICS1–3

Approximately 3–5% of patients with NSCLC are ALK+1

 

Patients with ALK+ NSCLC often have more advanced disease upon diagnosis compared with those with ALK-negative disease, and as many as 2 out of 3 will eventually develop CNS metastases2,3

THE IMPORTANCE OF BIOMARKER TESTING


IN ALK+ NSCLC

Overall, more than 50% of patients with advanced NSCLC have an actionable oncogenic driver.4

 

In advanced NSCLC, targeted therapies for these oncogenic drivers have revolutionised the treatment paradigm and led to significant improvements in response and survival rates.5

Testing for oncogenic drivers, including ALK rearrangements in metastatic NSCLC is important for the identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit.6

Biomarker testing is also important in early-stage NSCLC. Following surgery, the risk of recurrence for some patients with early NSCLC remains high;7,8 patients with ALK+ NSCLC face a greater risk of recurrence compared with patients with ALK-negative disease8,9

Approximate 5-year recurrence rate 
in resected NSCLC with/without chemotherapy and/or radiotherapy10,11,*

40%

For patients (N=1718)
with Stage I NSCLC

75%

For patients (N=1247)
with Stage III NSCLC

A review of a global database of NSCLC (N=25,911 with pathological staging)
found that 5-year OS was12,†

80%

For Stage I‡ NSCLC

30%

For Stage III§ NSCLC

Testing early for PD-L1 expression, EGFR mutations and ALK rearrangements in resected NSCLC can help identify appropriate treatment regimens and should be performed before initiating systemic therapy6,13

NCCN

Guidelines®

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend testing for PD-L1 expression, EGFR mutations and ALK rearrangements in patients with resected, early-stage NSCLC (Stages IB–IIIA, Stage IIIB [T3,N2])6

 

Staging classified as per the 8th edition of the UICC/AJCC

Discover

ALECENSA

 

*Calculated from number of events for DFS (Figure 3 of Pignon J-P, et al. J Clin Oncol 2008;26(21):3552–3559).11 †Based on the proposed 8th edition UICC/AJCC cancer staging.12 ‡Includes Stages IA1, IA2, IA3 and IB. §Includes Stages IIIA and IIIB.12


AJCC: American Joint Committee on Cancer; ALK: anaplastic lymphoma kinase; CNS: central nervous system; DFS: disease-free survival; EGFR, epidermal growth factor receptor; N: lymph node; NCCN: National Comprehensive Cancer Network; NSCLC: non-small cell lung cancer; OS: overall survival; PD-L1: programmed death-ligand 1; SmPC: Summary of Product Characteristics; T: tumour; UICC: Union for International Cancer Control.


1. Cognigni V, et al. Cancers (Basel) 2022;14(19):4765; 2. Johung KL, et al. J Clin Oncol 2016;34(2):123–129; 3. Wu Y-L, et al. N Engl J Med 2024;390(14):1265–1276; 4. Sathiyapalan A and Ellis PM. JCO Oncol Pract 2024;20(1):7–9; 5. Le X, et al. Cancers (Basel) 2023;15(11)2917; 6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer v.5.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved (accessed July 2024). To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way; 7. West H, et al. Clin Lung Cancer 2023;24(3):260–268; 8. Shin SH, et al. J Thorac Dis 2018;10(6):3460–3467; 9. Yang P, et al. J Thorac Oncol 2012;7(1):90–97; 10. Lim JU. Tuberc Respir Dis (Seoul) 2023;86(1):14–22; 11. Pignon J-P, et al. J Clin Oncol 2008;26(21):3552–3559; 12. Goldstraw P, et al. J Thorac Oncol 2016;11(1):39–51; 13. Loh J, et al. Transl Lung Cancer Res 2022;11(7):1241–1246.