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FIRMAGON® licence and indication

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FIRMAGON® extended licence

FIRMAGON® is still the only GnRH antagonist approved before or after radiotherapy for patients with high-risk localised or locally advanced hormone-dependent prostate cancer.1-3

Localised prostate cancer
Locally advanced PCa
Metastatic PCa
Low Risk
Intermediate Risk
High Risk
PSA <10 ng/mL
PSA 10-20 ng/mL
PSA >20 ng/mL
Any PSA
Any PSA
+ Gleason score <7
OR Gleason score =7
OR Gleason score >7
Any Gleason score
Any Gleason score
cT1-2a
OR T2b
OR T2c
T3-4 or N1
T3/4, N1, M1
FIRMAGON® extended licence
FIRMAGON® initial licence

Adapted from European Association of Urology Guidelines, 20224

FIRMAGON® is indicated for the treatment of adult male patients with advanced hormone-dependent prostate cancer, also in combination with radiotherapy and as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally hormone-dependent dependent prostate cancer.1,2

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Extended Licence
References

References
1. FIRMAGON® 120 mg injection Summary of Product Characteristics. Ferring Pharmaceuticals Ltd. October 2022. Available at: https://www.medicines.org.uk/emc/product/6537. Last accessed: January 2024.
2. FIRMAGON® 80 mg injection Summary of Product Characteristics. Ferring Pharmaceuticals Ltd. October 2022. Available at: https://www.medicines.org.uk/emc/product/6535. Last accessed: January 2024.
3. Relugolix Summary of Product Characteristics. Available at: https://www.accord-healthcare-products.co.uk/products/o/orgovyx-tablets. Last accessed: January 2024.
4. EAU – EANM – ESTRO – ESUR – ISUP – SIOG Guidelines on Prostate Cancer, 2022. Available at: https://uroweb.org/guidelines/prostate-cancer. Last accessed: January 2024.

Job Code: UK-FN-2400010 - Date of Preparation: March 2024

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