dm+d

36792611000001105

New Medicines

Erleada High-risk, localised or locally advanced prostate cancer in adult men receiving primary radiation therapy

Information

Erleada
Licence extension / variation
Janssen
Johnson & Johnson

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Competitive androgen receptor inhibitor
Prostate cancer (PC) is the most common male cancer in the UK, with more than 35,000 new cases diagnosed annually. In the UK, the incidence of PC is 97 per 100,000 people.
High-risk, localised or locally advanced prostate cancer in adult men receiving primary radiation therapy
Oral

Erleada Metastatic, castration-resistant prostate cancer - in combination with abiraterone and prednisone in chemotherapy-naïve men

Information

Erleada
Licence extension / variation
Janssen
Johnson & Johnson

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Apr 21Johnson & Johnson will not be filing for use of apalutamide in combination with abiraterone in patients with chemotherapy-naïve mCRPC, after the ACIS trial showed it did not improve survival compared with abiraterone alone [10].

Category

Competitive androgen receptor inhibitor
Prostate cancer (PC) is the most common male cancer in the UK, with more than 35,000 new cases diagnosed annually. In the UK, the incidence of PC is 97 per 100,000 people.
Metastatic, castration-resistant prostate cancer - in combination with abiraterone and prednisone in chemotherapy-naïve men
Oral

Further information

Yes

Trial or other data

Feb 21Results announced at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium showed the ACIS study (NCT02257736) met its main goal of radiographic progression-free survival (rPFS). But it did not show a significant benefit over Zytiga alone in secondary goals including overall survival. Janssen said data from patient subgroups with luminal type in a PAM50 test, and tumours with average or high androgen receptor activity, warrant further investigation [10].

Evidence based evaluations