dm+d

441758000

New Medicines

FirmagonHigh risk localised and locally advanced hormone dependent prostate cancer - neoadjuvant therapy in combination with, or prior to, radiotherapy

Information

Firmagon
Licence extension / variation
Ferring
Ferring

Development and Regulatory status

Phase III Clinical Trials
Launched
Phase III Clinical Trials
Nov 21Approved in EU [5].
Sep 21Recommended for EU approval by CHMP – the new indications are “for treatment of high-risk localized and locally advanced hormone-dependent prostate cancer in combination with radiotherapy” and “as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone-dependent prostate cancer” [4].

Category

A selective gonadotrophin releasing hormone (GnRH) antagonist. Given in a starting dose of 240mg (as two consecutive injections of 120mg) followed by a maintenance dose of 80mg on days 28 and 56.
The age-standardised incidence of prostate cancer in England in 2016 was 173.7 per 100,000 in 2016 [1].
High risk localised and locally advanced hormone dependent prostate cancer - neoadjuvant therapy in combination with, or prior to, radiotherapy
Subcutaneous injection

Trial or other data

Sep 11PIII trial completes (NCT00833248). Degarelix was non-inferior to combination therapy with goserelin and bicalutamide at reducing total prostate volume prior to radiotherapy [2,3].
Apr 09PIII trial to assess if degarelix reduces the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy starts (NCT00833248). The degarelix doses will be administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix administered as single 4 mL s.c. injections on Days 28 and 56, respectively. It will be compared with goserelin (3.6 mg) + bicalutamide (50 mg). On Day 0, the participants begin once-daily oral treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant is inserted s.c. into the abdominal wall. The second and third doses of goserelin administered on Days 31 and 59, respectively. 246 adult men will be recruited in countries including the UK, US, France, Germany, Greece, Netherlands and Spain. Primary outcome is change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 [2].

Evidence based evaluations

FirmagonPrevention of cardiovascular events in men with advanced prostate cancer

Information

Firmagon
Licence extension / variation
Ferring
Ferring

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A selective gonadotrophin releasing hormone (GnRH) antagonist
In the UK, prostate cancer (PC) is the most common cancer in men, with approximately 45,400 diagnoses and 10,600 deaths attributed to PC in 2012. Additionally, men with PC represent a high-risk population for cardiovascular disease, with many of the risk factors for PC being associated with high risk of CVD (e.g. obesity, diet, sedentary lifestyle). The commonest non-PC cause of death in such men is CVD [3].
Prevention of cardiovascular events in men with advanced prostate cancer
Subcutaneous injection