Bayer's Nubeqa Receives FDA Priority Review for New Indication in Metastatic Hormone-Sensitive Prostate Cancer

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Recently, Bayer announced that the U.S. FDA has accepted a supplemental New Drug Application (sNDA) for Nubeqa (darolutamide), a new prostate cancer drug, for use in combination with chemotherapy to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC).

This application is based on the positive results of a pivotal Phase 3 ARASENS trial, with related findings presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The data showed that, in patients with mHSPC, compared to the group receiving androgen deprivation therapy (ADT) plus chemotherapy (docetaxel), the group treated with Nubeqa + ADT + chemotherapy (docetaxel) demonstrated a statistically significant improvement in overall survival (OS) and a notable 32.5% reduction in the risk of death.

Nubeqa, an oral androgen receptor inhibitor jointly developed by Bayer and Orion, has been approved for marketing in more than 60 countries worldwide, including the United States, the European Union, Japan, and China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Recently, Bayer also submitted a new indication application for Nubeqa to treat mHSPC to the regulatory authorities in the European Union, Japan, and China.

It is reported that Bayer has high hopes for Nubeqa, previously predicting that the drug's annual sales peak would reach 1 billion euros. Based on the positive data from the Phase 3 ARASENS trial, Bayer raised the annual sales peak of Nubeqa, which is expected to reach 3 billion euros. The company has not yet reported the sales of Nubeqa, but it is expected that Nubeqa's revenue in 2021 will reach 200-250 million US dollars.

If the mHSPC indication is approved, Nubeqa will compete with Pfizer/Astellas’ Xtandi and Johnson & Johnson’s Erleada. It is reported that Xtandi was approved for marketing in 2012, with sales reaching $4.2 billion last year; while Erleada was approved in 2018, generating $1.3 billion in sales last year.

Reference Source:

1、Bayer's Nubeqa one step closer to blockbuster status thanks to FDA priority review in potential new use

2、FDA Accepts Bayer's Application to Expand Nubeqa into New Prostate Cancer Indication