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XTANDI 40 mg (enzalutamide)

Opinions on drugs - Posted on Nov 18 2021

Reason for request

New indication

Key points

Favourable opinion for reimbursement in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

What therapeutic improvement?

XTANDI (enzalutamide), in combination with ADT, provides a therapeutic improvement compared to ADT alone, in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

Role in the care pathway?

The first-line treatment of metastatic hormone-sensitive prostate cancer is based on androgen deprivation therapy (ADT), in combination with either apalutamide or abiraterone acetate plus prednisone or prednisolone, or docetaxel in patients eligible for chemotherapy. These strategies had demonstrated an improvement in overall survival compared to ADT alone.

Role of XTANDI (enzalutamide) in the care pathway:

XTANDI (enzalutamide) in combination with ADT is a first-line option in the treatment of patients with metastatic hormone-sensitive prostate cancer.

In the absence of comparative data, the role of XTANDI (enzalutamide) versus the other available first-line treatment options, i.e., apalutamide, docetaxel or abiraterone acetate (in combination with prednisone or prednisolone) remains to be determined.

According to the experts, the choice of treatment should take into account the patient’s age and comorbidities, the patient’s informed choice and the level of evidence and the safety profile of each medicinal product.

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of XTANDI (enzalutamide) is substantial in the MA indication.


Clinical Added Value

minor
  • demonstration of an improvement in overall survival with the enzalutamide + ADT combination versus ADT alone in only one of the two studies submitted (the ENZAMET open-label study, HR = 0.67; CI95% = [0.52; 0.86]) but not confirmed at this stage in the second phase 3, randomised double-blind study (the ARCHES study),
  • the superiority in terms of radiologic progression-free survival (15.5% versus 34.4%; HR = 0.39, CI95% = [0.30; 0.50]) demonstrated in the ARCHES study,
  • the safety profile of XTANDI (enzalutamide) in combination with ADT, deemed to be acceptable compared to the placebo + ADT combination with, respectively, 23.6% and 24.7% grade ≥ 3 adverse events,

 but considering, on the other hand:

  • uncertainties related to the non-availability of the results of the final analysis of the ARCHES study, in a context in which the interim analysis dates from October 2018, and
  • the absence of demonstration of an improvement in quality of life,

the Transparency Committee considers that XTANDI (enzalutamide) in combination with androgen deprivation therapy (ADT) provides a minor clinical added value (CAV IV) compared to ADT alone, in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).