Analyst views prospects for Nubeqa in the prostate cancer market

2 August 2019

Following the news that Bayer (BAYN: DE) and Orion’s (Nasdaq: OMX) Nubeqa (darolutamide) has gained US Food and Drug Administration approval for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC) in only five months, GlobalData’s healthcare director Heather Leach offers her views on the impact of the drug on the prostate cancer market.

According to Dr Leach, Nubeqa will face several challenges. Firstly, Key Opinion Leaders (KOLs) interviewed by GlobalData did not believe that nmCRPC has a large addressable market. Plus, outside of its late-to-market status, reimbursement of this high-cost drug regimen may face pushback from payers, as evidenced by NICE’s recommendation against Pfizer and Astellas’ (TYO: 4503) Xtandi (enzalutamide) in this setting.

“Nonetheless, GlobalData expects that Nubeqa will gain regulatory approval in the EU and Japan next year, alongside an extension of its indication to metastatic hormone-naïve patients in a few years’ time,” she said.

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