Approved
Hormone Therapy

darolutamide (NUBEQA®)

Primo-indication

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 docetaxel and androgen deprivation therapy (see section 5.1).

Intervention Type

Pharmaceutical

Solid/Hematological

Solid

Cancer Type

Prostate

Therapy Types

Hormone Therapy

Regulatory

FDA

N/A

Regulatory Pathway: n/a

EMA

27.03.2020

Regulatory Pathway: standard approval

Availability in other countries

N/A

Focus Area

Cancer

ASMR

III

Medical Need

Partially met

SMR

IMPORTANT

Orphan Status

No

Other resources