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Nubeqa
Published
Product name
Nubeqa
Active ingredient
Darolutamide
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Nubeqa (darolutamide) was approved for the following therapeutic use:
Nubeqa is indicated for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).
How this medicine works
Darolutamide is a non-steroidal androgen receptor antagonist with a flexible polar-substituted pyrazole structure that binds with nanomolar affinity directly to the receptor ligand binding domain to retain antagonistic activity against the androgen receptor (AR). Darolutamide competitively inhibits androgen binding, androgen receptor nuclear translocation and AR mediated transcription. Darolutamide had significant in vivo anti-tumour efficacy (decreased tumour cell proliferation) leading to decreased tumour volume in xenograft models of prostate cancer implemented in mice, including the castration-resistant model VCaP which overexpresses the AR.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Nubeqa was considered favourable for the therapeutic use approved.
Sponsor