Anatomical representation of the male urinary system.
Lhe scope of reimbursement in the city (100%) and approval by local authorities of FIRMAGON powder and solvent for solution for subcutaneous injection (degarelix) now covers all of its indications (cf. framed), with the addition of the following two [1,2] :
- treatment of localized high-risk or locally advanced hormone-dependent prostate cancer in combination with radiotherapy;
- neoadjuvant treatment to radiotherapy in patients with localized high-risk or locally advanced hormone-dependent prostate cancer.
These indications, now supported, are recent: they were added to the marketing authorization (AMM) for FIRMAGON in October 2021.
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FIRMAGON is a gonadotropin-releasing hormone (GnRH) antagonist, indicated:
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The two dosages of FIRMAGON currently available in France are affected by this extension of coverage:
- FIRMAGON 80 mg powder in vial + solvent in vial (CIP 3400939432687) ;
- FIRMAGON 120 mg powder in vial + solvent in vial (CIP 3400939432748).
In its opinion of April 20, 2022 [3]the Transparency Committee (CT) assessed FIRMAGON in its two new indications on the basis in particular of a non-inferiority, randomized, open-label study [4]having demonstrated the non-inferiority of FIRMAGON as a neoadjuvant compared with the goserelin + bicalutamide combination, in terms of mean change in total prostate volume at 12 weeks, in patients with intermediate-risk or high-risk prostate cancer.
On the basis of the available data, the CT judged that FIRMAGON provided a significant actual benefit (SMR), with no improvement in the SMR (ASMR V) in the management of localized high-risk or locally advanced hormone-dependent prostate cancer, as a neoadjuvant to radiotherapy or in combination with radiotherapy.