Download opinion
Add to my selection
Quote this publication Print

BLENREP (belantamab mafodotin)

Opinions on drugs - Posted on Dec 18 2020

Reason for request

First assessment

Key points

Favourable opinion for reimbursement as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

In heavily pretreated patients in the very advanced stages of the disease, in particular those who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody such as daratumumab (DARZALEX), there are no validated treatment options following the failure of an anti-CD38 antibody and patients are usually in a situation where all the treatment options have been exhausted.

Role of the medicinal product in the care pathway

Considering:

  • early efficacy data having demonstrated, in around one hundred patients, the benefit of BLENREP for obtaining an overall response in the management of advanced multiple myeloma following the failure of an anti-CD38 antibody (around 32% of the population in the group of patients having received the dose indicated by the MA, i.e., 2.5 mg/kg (CI97.5% [21.7; 43.6]), with a median response duration of 11 months),
  • the extremely limited experience (around 13 months) and the resulting uncertainties relative to the efficacy and maintenance of efficacy,
  • the safety profile, marked in the short term by eye disorders, in particular keratopathy, requiring appropriate monitoring, and infusion reactions,
  • the value of having access to a new mechanism of action targeting the BCMA receptor in salvage situations,
  • and pending additional data,

BLENREP (belantamab mafodotin) is a salvage therapy for multiple myeloma when all the other treatment options have been exhausted, following the opinion of a multidisciplinary team (MDT) meeting.

 

 

 


Clinical Benefit
Substantial

The Committee deems that the clinical benefit of BLENREP (belantamab mafodotin) is substantial “as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy”.

 

Clinical Added Value
no clinical added value

Considering:

  • the short-term efficacy data obtained relative to the overall response (around 32% of the population in the group of patients having received the dose indicated by the MA, i.e., 2.5 mg/kg (CI97.5% [21.7; 43.6]), with a median response duration of 11 months), in life-threatening clinical situations in which the treatment options are limited,
  • uncertainties concerning the clinical relevance of the primary endpoint used (overall response rate) and its transposability to overall survival time or improvement of quality of life.
  • uncertainties with respect to the real effect size of this medicinal product in the absence of comparative data, in a context in which a formalised comparison with a historic patient cohort could theoretically have been envisaged but was not performed,
  • uncertainties with respect to the clinical efficacy and its longer-term maintenance, in a context of extremely short follow-up (median follow-up of around 13 months),
  • the significant short-term toxicity, with a specific profile, particularly ocular (with grade 3 or 4 keratopathy reported in 30% of patients in the 2.5 mg/kg group), and the absence of long-term safety data,
  • and despite the benefit of having access to a medicinal product having been assessed following the failure of an anti-CD38 antibody in a context of an unmet medical need,

the Transparency Committee considers that, on the basis of currently available data, BLENREP (belantamab mafodotin) provides no clinical added value (CAV V) in the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Documents

English version

Contact Us

Évaluation des médicaments
All our publications