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ALUNBRIG

Opinions on drugs - Posted on Sep 15 2020

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the indication “as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with a tyrosine kinase inhibitor that targets the ALK+ mutation”.

What therapeutic improvement?

ALUNBRIG (brigatinib) provides a therapeutic improvement compared to crizotinib in the first-line treatment of advanced non-small cell lung cancer (NSCLC) with ALK gene rearrangement (ALK positive).

Role in the care pathway?

In the case of ALK-positive NSCLC, treatment has been significantly modified by the arrival of anti-ALK targeted therapies, the first of which was crizotinib, which has demonstrated its superiority compared to systemic chemotherapy. Other anti-ALK TKIs have been developed subsequently (ceritinib and alectinib). Given its demonstrated superiority versus crizotinib in terms of progression-free survival and risk of intracranial disease progression, alectinib (ALECENSA) is the option to be favoured in the first-line treatment of ALK+ lung cancer.

Role of the medicinal product in the care pathway:

ALUNBRIG (brigatinib) as monotherapy is a first-line treatment for advanced non-small cell lung cancer (NSCLC) with ALK gene rearrangement (ALK positive). Its superiority compared to crizotinib has only been demonstrated in terms of progression-free survival. In the absence of any comparative data, its role compared to alectinib remains to be specified. However, the level of demonstration of each drug and its safety profile must be taken into account when choosing a first-line anti-ALK therapy. In this context, alectinib has demonstrated an effect on brain metastases.

Furthermore, the conditions of use can be discussed in the event of sensitivity of the mutation to the drug (as determined by resistance phenotyping mechanisms by “liquid biopsy” or in situ sampling), and as an option following consideration of the benefit/safety ratio in other cases.

 


Clinical Benefit

Substantial

The clinical benefit of ALUNBRIG (brigatinib) is substantial in this new MA indication.


Clinical Added Value

minor

Taking into account both:

  • the demonstration in a phase III open-label study of a superiority compared to crizotinib in terms of progression-free survival (primary endpoint: median not reached in the brigatinib group versus 9.8 months in the crizotinib group (HR = 0.492 (95% CI: [0.33; 0.74]),
  • the absence of any possible conclusion with respect to an increase in overall survival given discontinuation of the analysis sequence for the second ranked endpoint,
  • the absence of demonstration of an improvement in quality of life,
  • the safety profile of brigatinib, which is acceptable but with an important identified risk of pulmonary toxicity according to the RMP, in particular pneumonitis,

the Committee considers that ALUNBRIG (brigatinib) provides a minor clinical added value (CAV IV) compared to crizotinib in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with a tyrosine kinase inhibitor that targets the ALK+ mutation.

 


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