NICE Issues Draft Guidance for Xofigo® (Radium-223 Dichloride) for Treating Hormone-Relapsed Prostate Cancer with Bone Metastases in an Additional Group of Men

Newbury, September 2, 2016 – The National Institute for Health and Care Excellence (NICE) has recommended Xofigo^® (radium-223 dichloride) in their draft guidance for adult men with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases where docetaxel is contraindicated or is not suitable.¹

Radium-223 already has full NICE guidance in England for adult men with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases who have previously received docetaxel therapy² and this draft guidance is an extended approval to include an additional group of men.

Dr Amit Bahl, Consultant Oncologist at Bristol Cancer Institute, University Hospitals Bristol said “This news is a step forward for men with prostate cancer as there are limited treatment options available in this group of men.”

Prostate cancer is the most common cancer affecting men in the UK.³ There are about 41,700 men diagnosed with prostate cancer each year, which is more than 110 every day.⁴ In some cases prostate cancer may spread to other parts of the body, particularly the bones, in certain cases leading to debilitating pain,^3,5 and/or bone fractures.⁶

Dr Alexander Moscho, CEO Bayer UK & Ireland said, “Bayer is pleased that NICE has extended their guidance to include an additional recommendation for radium-223. NICE has already recommended radium-223 for patients post-docetaxel and this positive draft guidance marks a significant step in Bayer’s ongoing dedication to addressing unmet clinical needs in prostate cancer.”

Radium-223 is the first alpha-particle emitting radioactive therapeutic agent recommended for use for the treatment of adult men with metastatic hormone relapsed prostate cancer within the NHS. Bone metastases are a significant cause of mortality in these patients⁷ and the availability of radium-223 on the NHS will enable doctors and physicians to better manage the disease.

In the phase III ALSYMPCA study, radium-223 dichloride was shown to significantly extend median overall survival (OS), the primary endpoint of the study. Median OS was 14.9 months for radium-223 dichloride compared to 11.3 months for placebo (HR=0.70 [95% CI, 0.58-0.83]; p<0.001).⁸ In addition, there was a delay in the time to first symptomatic skeletal event for patients treated with radium-223 dichloride compared to placebo (HR=0.66 [95% CI, 0.52-0.83] p<0.001).⁸

The most frequently observed adverse reactions (≥10%) in patients receiving radium-223 dichloride were diarrhoea, nausea, vomiting and thrombocytopenia.⁹

Radium-223 dichloride was approved for the treatment of adult men with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases, in November 2013 in the European Union.¹⁰

Notes to Editor

About Xofigo (radium-223 dichloride)
Radium-223 dichloride is an alpha particle-emitting pharmaceutical. Its active moiety mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent tumour cells, resulting in a potent cytotoxic effect. Additional effects on the tumour microenvironment including osteoblasts and osteoclasts also contribute to the in vivoefficacy. The alpha particle range from radium-223 is less than 100 micrometers (less than 10 cell diameters) which minimises damage to the surrounding normal tissue.

A full Summary of Product Characteristics for Xofigo has been included as an attachment accompanying this press release.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritises targets and pathways with the potential to impact the way that cancer is treated.

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References

1. [National Institute for Health and Care Excellence. NICE Final Appraisal Determination. Radium-223 dichoride for treating hormone-relapsed prostate cancer with bone metastases. Available at: https://www.nice.org.uk/guidance/ta376 [Last access August 2016]
2. National Institute for Health and Care Excellence.  Radium-223 dichoride for treating hormone-relapsed prostate cancer with bone metastases. Available at: https://www.nice.org.uk/guidance/ta376/chapter/1-Recommendations [Last access August 2016]
3. MacMillan Cancer Support. About Prostate Cancer. May 2012. Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Prostate/Aboutprostatecancer/Prostatecancer.aspx[Last accessed August 2016]
4. Cancer Research. Prostate Cancer Incidence. Available at: http://www.cancerresearchuk.org/about-cancer/type/prostate-cancer/about/prostate-cancer-risks-and-causes [Last accessed August 2016]
5. Halabi S et al, Pain Predicts Overall Survival in Men With Metastatic Castration-Refractory Prostate Cancer. J Clin Oncol. 2008: 26;15:2544-2549. Available at: http://jco.ascopubs.org/content/26/15/2544.ful.pdf[Last access August 2016]
6. Prostate Cancer UK. Advanced prostate cancer: Managing symptoms. February 2015. Available at: http://prostatecanceruk.org/prostate-information/living-with-prostate-cancer/advanced-prostate-cancer-managing-symptoms [Last accessed August 2016]
7. N Sathiakumar, et al. Mortality Following Bone Metastasis and Skeletal-related Events Among Men with Prostate Cancer. Prostate Cancer Prostatic Dis. 2011; 14(2):177-183. DOI: 10.1038/pcan.2011.7
8. Parker C et al, Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer.N Engl J Med. 2013:369;3:213-223
9. Bayer. Summary of Product Characteristics. Xofigo 1100 kBq/mL solution for injection. 2015. Available at: https://www.medicines.org.uk/emc/medicine/28471#PRODUCTINFO [Last accessed August 2016]
10. European Medicines Agency. Xofigo (radium-223 dichloride). 2015. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002653/human_med_001692.jsp&mid=WC0b01ac058001d124 [Last accessed August 2016]

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