Johnson & Johnson's Erleada gains expanded FDA approval to include metastatic castration-sensitive prostate cancer

Johnson & Johnson's Janssen Pharmaceutical unit announced that the FDA expanded approval of the androgen receptor inhibitor Erleada (apalutamide) to include the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). The marketing application, which was submitted in April, was assessed under the FDA's Real-Time Oncology Review programme.

The approval is based on results from the Phase III TITAN study, which the company announced in January had met its primary endpoints of radiographic progression-free survival and overall survival (OS), with detailed results later reported at the American Society of Clinical Oncology (ASCO) annual meeting. The trial included 1052 patients with mCSPC regardless of extent of disease, including both high- and low- volume disease, or prior docetaxel treatment history.

Data from the trial showed that Erleada plus androgen deprivation therapy (ADT) reduced the risk of death by 33% versus placebo plus ADT, while the androgen receptor inhibitor was also associated with a 52% lower risk of radiographic progression or death. In addition, the two-year OS rates, after a median follow-up of 22.7 months, were 84% for Erleada plus ADT compared to 78% for placebo plus ADT.

"Erleada has the potential to change how patients with prostate cancer are treated, regardless of the extent of the disease or prior docetaxel treatment history," remarked Margaret Yu, prostate cancer disease area leader at Janssen Research & Development.

Erleada first gained clearance in the US in 2018 for the treatment of patients with non-metastatic castration-resistant prostate cancer. Johnson & Johnson previously identified the androgen receptor inhibitor as one of more than 10 drugs with blockbuster potential that it would launch or seek approval for through 2021.

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