FIRMAGON (degarelix)

Key points

Favourable opinion for maintenance of reimbursement in the treatment of advanced hormone-dependent prostate cancer.

What therapeutic improvement?

No clinical added value in the therapeutic strategy.

Role in the care pathway?

The current guidelines for the treatment of advanced hormone-dependent prostate cancer (locally advanced or metastatic) recommend:

• at the locally advanced stage (T3-T4): androgen deprivation hormone therapy using a GnRH agonist or antagonist combined with adjuvant external radiotherapy for 2 to 3 years (neoadjuvant use may also be considered for 4 to 6 months).

It should be noted that the care pathway has recently evolved, with, in particular, the integration of second-generation androgen receptor antagonists since 2019, in combination with androgen deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC): apalutamide (ERLEADA), enzalutamide (XTANDI) or darolutamide (NUBEQA), in high-risk patients (PSA doubling time < 10 months).

-    At the metastatic stage:

• In hormone-sensitive patients (mHSPC), ADT should be used in combination with second-generation androgen receptor antagonists [apalutamide (ERLEADA)] or abiraterone acetate (ZYTIGA) in combination with prednisone or prednisolone in newly diagnosed high-risk patients, or with docetaxel in patients eligible for chemotherapy and who cannot receive the previously mentioned treatments. External radiotherapy may potentially be used for low-volume tumours.
• In castration-resistant patients (mCRPC), castration should be maintained and chemotherapy (docetaxel, cabazitaxel in patients previously treated with docetaxel) or second-generation hormone therapy [abiraterone acetate (ZYTIGA), enzalutamide (XTANDI)] may be proposed. It should be noted that radium 223 (XOFIGO) only has an MA in the event of bone metastases after two prior treatment lines.

Androgen deprivation therapy at non-metastatic stages (as an adjuvant to external radiotherapy in locally advanced stage T3-T4 tumours) and at metastatic stages includes two treatment classes, a GnRH antagonist, FIRMAGON (degarelix), and GnRH agonists (groserelin, triptorelin, leuprorelin). In the event of treatment with a GnRH agonist alone, temporary hypertestosteronaemia (flare up effect) may be observed. This effect is not observed with degarelix. A first-generation antiandrogen (bicalutamide, nilutamide, flutamide) generally used to be combined with the GnRH agonist for a short period of time in order to prevent the clinical consequences of serum testosterone peaks. Since the arrival of second-generation androgen receptor antagonists in combination with androgen deprivation therapy and the evolution of the care pathway, the use of first-generation antiandrogens has been limited (only in the context of complete androgen blockade).

Role of the medicinal product in the care pathway

FIRMAGON (degarelix) proprietary medicinal products represent an alternative to GnRH agonists (groserelin, triptorelin, leuprorelin) as a first-line treatment in the care pathway for hormone-dependent prostate cancer at locally advanced non-metastatic stages (stages T3 to T4) and at metastatic stages with lymph node involvement (N+) or with distant metastasis (M+).