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Prostate Cancer: Update Bulletin #1 [January 2019]

Product Code:
Publication Date:
January 2019

This edition presents key opinion leader (KOL) views on recent developments in the prostate cancer market. Topics covered include: Bayer and Orion announcing that their androgen receptor antagonist darolutamide (ODM-201) had met the primary endpoint in the Phase III ARAMIS trial in patients with high-risk, non-metastatic, castration-resistant prostate cancer (nmCRPC); Janssen announcing that the European Commission (EC) had granted approval for its androgen receptor antagonist Erleada (apalutamide) for patients with nmCRPC who are at high risk of developing metastatic disease; Astellas announcing that the androgen receptor antagonist Xtandi (enzalutamide), which it is jointly developing and commercialising with Pfizer, had received European approval for the treatment of high-risk nmCRPC, and that the Phase III ARCHES trial investigating Xtandi/ADT in patients with mHSPC, had met its primary endpoint.

Business Questions:

• How does darolutamide compare with other androgen receptor antagonists, such as Xtandi and Erleada, in terms of efficacy and safety?
• To what extent will darolutamide’s late arrival on the market affect its uptake as a treatment for prostate cancer?
• Could a positive outcome for the ARASENS trial impact on treatment practice within the mHSPC setting?
• Since its approval as a treatment for nmCRPC in February 2018, which factors have had the greatest influence on the level of Erleada use in the US?
• Following its recent approval for nmCRPC in Europe, how widespread is the use of Erleada likely to become in this setting?
• Do KOLs foresee any obstacles to Erleada’s success as an mHSPC therapy, assuming that it eventually receives approval for this indication?
• Is the expansion of Xtandi’s label to include nmCRPC in Europe likely to result in significant additional use of this anti-androgen drug?
• Will the positive result demonstrated by Xtandi in the ARCHES trial be sufficient to guarantee its success as a treatment for mHSPC?


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