Nubeqa

darolutamide

Table of contents

Opinion

On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nubeqa, intended for the treatment of prostate cancer. The applicant for this medicinal product is Bayer AG.

Nubeqa will be available as 300-mg film-coated tablets. The active substance of Nubeqa is darolutamide, an androgen receptor inhibitor (ATC code: L02BB06) that binds directly to the receptor ligand binding domain.

The benefits with Nubeqa are its ability to delay metastatic disease in patients with non-metastatic castration-resistant prostate cancer. The most common side effect is fatigue.

The full indication is:

“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”.

It is proposed that Nubeqa be prescribed by a specialist physician experienced in treatment of prostate cancer.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Nubeqa
Agency product number
EMEA/H/C/004790
International non-proprietary name (INN) or common name
  • darolutamide
Active substance
  • darolutamide
Therapeutic area
Prostatic Neoplasms, Castration-Resistant
Date opinion adopted
30/01/2020
Company name
Bayer AG
Status
Positive
Application type
Initial authorisation

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