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RYBREVANT (amivantamab) - Non-small cell lung cancer (NSCLC)

Opinions on drugs - Posted on Apr 27 2023

Reason for request

Reassessment

Reassessment.

Key points

Favourable opinion on reimbursement “as monotherapy in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy.“

Role in the care pathway?

Despite the low level of proof of the data, and while waiting for new data on efficacy and safety, the Committee considers that RYBREVANT (amivantamab), in monotherapy, is a treatment option in the management of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.

Considering the absence of comparative data with acceptable methodological quality, the role of RYBREVANT (amivantamab) in relation to the available therapeutic alternatives (chemotherapy) cannot be specified. It should be emphasized that, in this context, the introduction of this medicinal product into the therapeutic strategy is associated with a greater risk than for medicinal products for which their efficacy has been based on a comparison made using an appropriate methodology.


Clinical Benefit
Low

The clinical benefit (CB) provided by RYBREVANT (amivantamab) is low in the MA indication.

Clinical Added Value
no clinical added value

In view of:

  • the poor demonstration of efficacy of RYBREVANT (amivantamab), based on data from a phase I/II single-arm study;
  • the uncertainty regarding the relative efficacy of RYBREVANT, considering the absence of a direct comparison and of the methodological weakness of the indirect comparison provided, in a context where a direct comparison with an available therapeutic alternative with a robust methodology was possible ;
  • the safety profile, marked by an incidence of adverse events of grades ≥ 3 noted in 41.8 % of patients;
  • the medical need highlighted by experts;

the Transparency Committee considers that in the current state of the dossier, RYBREVANT (amivantamab) provides no clinical added value (CAV V) in the management of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, after failure of platinum-based therapy.

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