Nubeqa - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

darolutamide

Opinion

On 19 June 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Nubeqa. The marketing authorisation holder for this medicinal product is Bayer AG.

The CHMP adopted a new indication to include treatment of adult men with hormone-sensitive metastatic prostate cancer, in combination with androgen deprivation therapy. The full indications for Nubeqa will therefore be as follows:¹

NUBEQA is indicated for the treatment of adult men with

• non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).
• metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).
• metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹ New text in bold

CHMP post-authorisation summary of positive opinion for Nubeqa (II-24)

AdoptedReference Number: EMA/CHMP/141494/2025

Key facts

• Name of medicine:
  Nubeqa
• EMA product number:
  EMEA/H/C/004790
• Active substance:
  darolutamide
• International non-proprietary name (INN) or common name:
  darolutamide
• Therapeutic area (MeSH):
  Prostatic Neoplasms, Castration-Resistant
• Anatomical therapeutical chemical (ATC) code:
  L02BB
• Marketing authorisation holder:
  Bayer AG
• Date of opinion:
  19/06/2025
• Status:
  Positive