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About Xofigo®▼ (radium-223 dichloride) in mCRPC

For adult patients with metastatic castration-resistant prostate cancer (mCRPC)

Xofigo (+ best standard of care) is the first targeted alpha therapy to improve overall survival and slow down the decline of quality of life during on treatment period vs placebo + best standard of care (BSC) in mCRPC patients with symptomatic bone metastases and no known visceral metastases.

Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with mCRPC, symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.

Xofigo
▼
Prescribing Information

    Xofigo is fully funded throughout the UK

    Approved by NICE

    Xofigo is NICE recommended as an option for treating patients with hormone-relapsed prostate cancer with 2 or more symptomatic bone metastases and no known visceral metastases if they have experienced disease progression after at least 2 lines of prior systemic therapy (other than LHRH analogues) or are ineligible for available systemic therapy options.

     

    SMC accepted

    For the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases

     

    To find out more, see Guidelines

    mCRPC patients with symptomatic bone metastases should be treated early with Xofigo (prior to visceral metastases)

    Introduce Xofigo for your mCRPC patients who have progressed on two lines of systemic therapy (other than LHRH analogues) or if ineligible for systemic therapy.

    Xofigo
    ▼
    Prescribing Information

    Identifying the right patients for treatment with Xofigo

    Inclusion criteria for Xofigo following 2 prior lines or ineligible for systemic therapy

    Inclusion criteria for Xofigo following 2 prior lines of ineligible for systemic therapy

    Xofigo is not recommended in patients with a low level of osteoblastic bone metastases.

    How Xofigo may fit in to your treatment sequence

    mage_2023-10-27_123528559

    These are illustrative algorithms based on the revised EU indication for Xofigo. Not all potential treatment options are shown. Concurrent use of bone health agents to treat osteoporosis or for patients with bone metastases is recommended. Sequential use of abiraterone and enzalutamide (or vice versa) is not considered as an option due to likely futility of treatment. Consider clinical trials or best supportive care after all available systemic therapies have been administered.

    Abbreviations: ADT:
    androgen deprivation therapy;
    AR:
     androgen receptor; 
    EU:
     European Union;
    LHRH:
     Luteinising hormone releasing hormone;
    mCRPC:
     metastatic castration-resistant prostate cancer;
    mHSPC:
     metastatic hormone-sensitive prostate cancer;
    nmCRPC:
     non-metastatic castration-resistant prostate cancer.

     

    Use Xofigo while there is an opportunity for action before the development of visceral metastases

    Xofigo + BSC significantly extended median OS vs placebo + BSC

    In the phase 3 ALSYMPCA trial, an updated analysis showed that

    Xofigo + BSC significantly extended median OS by 3.6 month
    vs placebo + BSC (14.9 months vs 11.3 months, respectively; P<0.001).

    Median OS

    image_2023-10-27_124427791

    Adapted from Parker C et al. 2013. ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with 2 or more bone metastases. Patients were randomised 2:1 to receive 6 injections (one every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. The primary endpoint was overall survival.

    Abbreviations: BSC:
    best standard of care;
    EBRT:
     external beam radiation therapy;
    mCRPC:
     metastatic castration-resistant prostate cancer;
    OS:
     overall survival.

     

    Xofigo + BSC significantly delays time to first symptomatic skeletal event (SSE) vs placebo + BSC

    In the phase 3 ALSYMPCA trial, an updated analysis of secondary endpoints showed that

    Xofigo + BSC significantly delayed time to first SSE by 5.8 months
    vs placebo + BSC (15.6 months vs 9.8 months, respectively; P<0.001).

    Median time to first SSE

    image_2023-10-27_124617038

    Adapted from Parker C et al. 2013. ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. Patients were randomised 2:1 to receive 6 injections (one every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. SSEs were defined as EBRT for pain relief, spinal cord compression, tumour-related orthopaedic surgical interventions, bone fractures. The primary endpoint was overall survival.

    Abbreviations: BSOC:
    best standard of care;
    EBRT:
     external beam radiation therapy;
    mCRPC:
     metastatic castration-resistant prostate cancer;
    OS:
     overall survival;
    SSE:
     symptomatic skeletal event.

     

    Improved survival with Xofigo + BSC is accompanied by a slower decline in quality of life vs placebo + BSC

    A post hoc analysis of the phase 3 ALSYMPCA trial showed that

    significantly more patients treated with Xofigo + BSC experienced a meaningful improvement in quality of life
    (as measured by FACT-P total score or EQ-5D utility score) vs placebo + BSC (P=0.02 and P=0.004, respectively).

    In addition,

    significantly more patients experienced pain relief with Xofigo + BSC
    than placebo + BSC (30.2% [129/427] vs 20.1% [37/184], respectively; P=0.01)

    Patients with a meaningful improvement in FACT-P total score and EQ-5D utility score

    image_2024-01-31.jpg

    Adapted from Nilsson S et al. 2016. ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. Patients were randomised 2:1 to receive 6 injections (one every 4 weeks) of Xofigo + BSC (n=614) or placebo + BSC (307). BSC included local EBRT or treatment with bisphosphonates, corticosteroids, antiandrogens, oestrogens, estramustine, or ketoconazole. The primary endpoint was overall survival. A post hoc analysis looked at health-related quality of life using two validated instruments: the general EQ-5D and the disease-specific FACT-P. Meaningful improvement defined as increase in FACT-P total score of ≥10 from baseline or an increase in EQ-5D utility score of ≥0.1 from baseline, at Week 16 and/or Week 24.

    Abbreviations: BSOC:
    best standard of care;
    EBRT:
     external beam radiation therapy; EQ-5D: EuroQoL 5D;
    FACT-P:
     Functional Assessment of Cancer Therapy-Prostate;
    mCRPC:
     metastatic castration-resistant prostate cancer.

    Safety profile of Xofigo + BSC was comparable to placebo + BSC

    In the phase 3 ALSYMPCA trial, the rates of AEs were similar with Xofigo + BSC vs placebo + BSC.

    image_2023-10-27_124951149

    ALSYMPCA was a double-blind, randomised, placebo-controlled, phase 3 study in 921 symptomatic mCRPC patients with bone metastases. The safety population included 600 patients in the Xofigo + BSC group and 301 patients in the placebo + BSC group.

    • The most frequently observed adverse reactions (≥ 10%) in patients receiving Xofigo were diarrhoea, nausea, vomiting, thrombocytopenia and bone fracture
    • The most serious adverse reactions were thrombocytopenia and neutropenia
    • Xofigo increases the risk of bone fractures. In clinical studies, concurrent use of bisphosphonates or denosumab reduced the incidence of fractures in patients treated with Xofigo

    For the full list of AEs, please refer to the SMPC link below:

    Xofigo
    ▼
    Prescribing Information

     

    Treatment considerations

    • Chemotherapy may be used after Xofigo*

    *The haematological safety profiles for patients receiving chemotherapy after Xofigo were similar to those seen in patients receiving chemotherapy after placebo.

     

    Patient considerations

    • Low incidence of Grade 3–4 vomiting
    • Can be administered without the need for steroids†

    †Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Concomitant use of steroids may further increase the risk of fracture.

    Abbreviations: AE:
    adverse event;
    BSOC:
     best standard of care;
    mCRPC:
     metastatic castration-resistant prostate cancer.

    Xofigo has a fixed course of treatment

    Xofigo is administered as a 1-minute IV injection every 4 weeks for 6 injections.

    Treat for all 6 cycles of Xofigo to maximise overall survival benefit

    Help your patients experience the benefits of Xofigo

    image_2024-01-31_1

    Use of Xofigo is not recommended in patients with low levels of osteoblastic bone metastases.

    Abbreviations: OS:
    overall survival;
    SSE:
     symptomatic skeletal event;
    QoL:
     quality of life

PP-XOF-GB-0743 | March 2026

    • 1
      Xofigo® Summary of Product Characteristics.
    • 2
      Parker C, et al. Prostate Cancer Prostatic Dis. 2018;21(1):37-47.
    • 3
      Parker C, et al. N Engl J Med. 2013;369(3):213-223.
    • 4
      Nilsson S, et al. Ann Oncol. 2016;27(5):868-874.
    • 5
      Suominen MI, et al. Clin Cancer Res. 2017;23(15):4335-4346.
    • 6
      Nilsson S, et al. Ann Oncol. 2016;27(5):868-874. Supplementary data.
    • 7
      NHS England. Cancer Drugs Fund List. Available from: https://www.england.nhs.uk/cancer/cdf/cancer-drugs-fund-list (Accessed April 2025).
    • 8
      Scottish Medicines Consortium. Advice 1077/15. 2015. Available at: https://www.scottishmedicines.org.uk/medicines-advice/radium-223-xofigo-fullsubmission-107715/ (Last Accessed April 2025).
    • 9
      National Comprehensive Cancer Network. NCCN Guidelines® Version 4.2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf (Last Accessed April 2025).
    • 10
      Parker C, et al. Ann Oncol. 2015;26(suppl 5):v69-v77.
    • 11
      O’Sullivan JM, et al. Eur Urol Oncol. 2019; doi:10.1016/j.euo.2019.02.007.
    • 12
      Shore ND. Urology. 2015;85(4):717-724.
    • 13
      Saad F, et al. Can Urol Assoc J. 2015;9(3-4):90-96.
    • 14
       Cookson MS, et al. J Urol. 2015;193(2):491-499.
    • 15
      Sartor O, et al. Prostate. 2016;76:905–916.
    • 16
      Data on File. XOF-001. Bayer. 2016.