Reason for request

First assessment

  • Key points

Favourable opinion for reimbursement in the treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.  

  • What therapeutic improvement?

No clinical added value.

  • Role in the care pathway?

The therapeutic arsenal for lung cancer has recently been expanded following the addition of specific treatments targeting this genome abnormality, as first-line therapy: ALECENSA (alectinib), ZYKADIA (ceritinib) and XALKORI (crizotinib) and as second-line therapy: ALECENSA (alectinib), ZYKADIA (ceritinib).

Role of LORVIQUA in the care pathway:

On the basis of currently available data, the Committee considers that LORVIQUA is a second or third-line treatment option. In the absence of comparative data, its precise role in the care pathway remains to be defined.



Clinical Benefit


The clinical benefit of LORVIQUA is low, as the dossier currently stands.

Clinical Added Value

no clinical added value


  • available data based on 3 cohorts among 7 derived from a phase 1/2 non comparative study in a heterogeneous population in second, third or later-line treatment,
  • the difficulty of precisely determining the effect size and role of this proprietary medicinal product in the treatment of advanced ALK+ lung cancer,


the Committee considers that LORVIQUA provides no clinical added value (CAV V) in the treatment of advanced ALK+ lung cancer.

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