Quote this publication Share Print

ERLEADA

Prostate cancer - New indication
Opinions on drugs - Posted on Jul 01 2020

Reason for request

New indication

New indication

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

What therapeutic improvement?

Like ZYTIGA (abiraterone acetate), ERLEADA (apalutamide), 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 docetaxel in patients eligible for chemotherapy, or on ADT plus abiraterone acetate in combination with prednisone or prednisolone. Both these strategies had demonstrated an improvement in overall survival compared to ADT alone.

Role of ERLEADA (apalutamide) in the care pathway:

ERLEADA administered in combination with ADT represents a new first-line option in the treatment of patients with metastatic hormone-sensitive prostate cancer.

In the absence of comparative data, the role of ERLEADA versus 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, comorbidities, the patient’s informed choice and the safety profile of each medicinal product.


Clinical Benefit

Substantial

The clinical benefit of ERLEADA is substantial in this MA indication extension.


Clinical Added Value

moderate

Considering:

  • demonstration of the superiority of the apalutamide + ADT combination versus ADT alone, particularly in terms of overall survival (death: 16% vs 22% in the comparator group, HR = 0.67; 95% CI [0.51; 0.89]) and radiographic progression-free survival (radiographic progression or death: 26% vs 44% in the comparator group, HR = 0.48; 95% CI [0.39; 0.60]),

and despite:

  • the absence of demonstration of an improvement in quality of life,
  • the acceptable safety profile of ERLEADA + ADT but with a potential risk of ischaemic heart disease (4% vs 2% under placebo),

the Committee considers that, like ZYTIGA (abiraterone acetate), ERLEADA (apalutamide) in combination with ADT, provides a moderate clinical added value (CAV III) versus ADT alone, in the indication “in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)”.


-

 

Contact Us

Évaluation des médicaments