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FDA expands Janssen's Erleada label to cover metastatic castration-sensitive prostate cancer

Published on 19/09/19 at 10:11am

Janssen has announced that the FDA has expanded the label of its androgen receptor inhibitor Erleada (apalutamide) to include the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).

The therapy was evaluated under Priority Review Designation through the US regulator’s Real-Time Oncology Review programme. It is estimated that around 40,000 new diagnoses of mCSPC are made in the US each year.

In Phase 3 trials investigating the use of the drug in a patient population chosen regardless of extent of disease, including both high- and low- volume disease, or prior docetaxel treatment history, the therapy was found to achieve statistical significance in the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) at the first pre-planned interim analysis

When combined with androgen deprivation therapy (ADT), Erleada was found to reduce the risk of death by 33% compared to placebo plus ADT, and “significantly improved” radiographic progression-free survival by 52%. Additionally, after a median follow-up of 22.7 months, two-year overall survival rates stood at 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, by delaying disease progression and prolonging survival," said Dr Margaret Yu, Vice President, Prostate Cancer Disease Area Leader at Janssen. “This milestone highlights Janssen's commitment to improve the standard of care for patients with prostate cancer as we continue to develop innovative treatments across the disease continuum.”

Matt Fellows

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