Bayer and Orion’s Nubeqa could gain regulatory approval in EU and Japan next year despite being late-to-market for prostate cancer

Following the news that Bayer and Orion’s Nubeqa (darolutamide) has gained US Food and Drug Administration (FDA) approval for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC) in only five months, Heather Leach, PhD, Healthcare Director at GlobalData, a leading data and analytics company, offers her view on the impact of Nubeqa on the prostate cancer market:

“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’s Xtandi 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.

“Although Nubeqa’s approval timeline is short in regulatory terms, other in-class agents were granted similar privileges, with their first FDA approvals granted within four months of the initial filing.

“Nubeqa is the fourth-in-class agent after Johnson & Johnson’s (J&J) Zytiga (abiraterone), Pfizer and Astellas’s Xtandi (enzalutamide) and J&J’s Erleada (apalutamide). Notably, it is also the third-to-market for nmCRPC patients, following the approvals of Xtandi and Erleada for nmCRPC in 2018. This was a label expansion for Xtandi, which was first approved for metastatic castration-resistant (mCRPC) patients, second to Zytiga in this setting.

“GlobalData does not expect Zytiga, which recently received pressure due to competition from generic entry in the US, to gain approval in nmCRPC.”

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