Janssen will not seek regulatory approval for Erleada plus Zytiga in prostate cancer
Decision follows mixed results from the phase 3 ACIS study
Johnson & Johnson’s (J&J) pharma division Janssen has announced that it will not pursue regulatory submissions for a combination of its androgen receptor inhibitor Erleada and hormonal therapy Zytiga in prostate cancer.
Specifically, Janssen will not pursue regulatory approval based on the phase 3 ACIS study, which evaluated Erleada (apalutamide) and Zytiga (abiraterone acetate) plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC).
The ACIS study met its primary endpoint of radiographic progression-free survival (rPFS), with a 31% reduction in the risk of radiographic progression or death in these patients.