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CABOMETYX (cabozantinib) - Carcinome thyroïdien différencié

Opinions on drugs - Posted on Dec 01 2022

Reason for request

New indication

Key points

Approval for reimbursement as monotherapy for the treatment of adult patients with progressive, radioactive iodine (RAI)-refractory or ineligible, locally advanced or metastatic differentiated thyroid carcinoma (DTC), during and after prior systemic treatment.

Therapeutic improvement?

Therapeutic improvement in the care of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), that is refractory to or ineligible for radioactive iodine (RAI) and progressive during and after prior systemic treatment. 

Role in therapeutic strategy?

In cases of locally advanced or metastatic differentiated thyroid cancer, that are inoperable and not susceptible to radioactive iodine treatment, the indication of systemic treatment may be discussed in the presence of progressive disease with large metastases.

In 2014, NEXAVAR (sorafenib), was granted a European marketing authorisation for the treatment of adult patients with progressive locally advanced or metastatic differentiated thyroid carcinoma (papillary, follicular, Hürthle cell), refractory to radioactive iodine (RAI), followed one year later by LENVIMA (lenvatinib) for the same indication.

The latest NCCN guidelines from 2022 in the United States propose CABOMETYX (cabozantinib) after progression with LENVIMA (lenvatinib) and/or NEXAVAR (sorafenib) treatment for aggressive and/or symptomatic forms (category 1), and the ESMO European guidelines of 2022 similarly consider cabozantinib as a treatment option for patients for progressive and/or symptomatic radioactive iodine-refractory advanced/metastatic differentiated cancer, after prior Multi Kinase Inhibitor treatment with lenvatinib or sorafenib (category [I, A]).

Role of the medicinal product

CABOMETYX (cabozantinib) is a second-line and subsequent treatment for adult patients with progressive, radioactive iodine (RAI)-refractory or ineligible, locally advanced or metastatic differentiated thyroid carcinoma (DTC), during and after prior systemic treatment.

Special recommendation

The Committee highlights the need for validation of the prescription of CABOMETYX (cabozantinib) by centres of excellence or in multidisciplinary review meetings including an oncologist or a differentiated thyroid cancer care specialist (endocrinologist).  

 


Clinical Benefit
Substantial

The Committee deems the actual clinical benefit of CABOMETYX (cabozantinib) to be significant for the marketing authorisation indication “as monotherapy for the treatment of adult patients with progressive, radioactive iodine (RAI)-refractory or ineligible, locally advanced or metastatic differentiated thyroid carcinoma (DTC), during and after prior systemic treatment”.

Clinical Added Value
minor

Considering:

  • the evidence in the COSMIC-311 phase III, randomised, double-blind study of the superiority of CABOMETYX (cabozantinib) versus placebo in terms of progression-free survival (PFS) where HR = 0.22 (96% CI [0.13; 0.36] ; p<0.0001),
  • the acceptability of the comparator (placebo) due to the almost exclusive use in French clinical practice of LENVIMA (lenvatinib) as a first-line treatment (expert opinion),

and despite:

  • the lack of evidence of superiority in terms of the response rate (second primary outcome measure of the study),
  • the lack of evidence of a gain in overall survival (exploratory secondary outcome measure of the study),
  • the lack of formal conclusions that can be drawn from the exploratory quality-of-life findings,
  • a safety profile marked by the onset of serious adverse events in one-third of patients, and grade ≥ 3 adverse events in approximately one-half of patients,

the Transparency Committee deems that CABOMETYX (cabozantinib) provides minor clinical added value (CAV IV), in terms of efficacy, for the treatment of progressive, radioactive iodine (RAI)-refractory or ineligible, locally advanced or metastatic differentiated thyroid carcinoma (DTC), during and after prior systemic treatment.

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