September 17, 2019

The US FDA has approved a new indication for Erleada® (apalutamide), manufactured by Janssen Pharmaceuticals. The product is now indicated to treat metastatic castration-sensitive prostate cancer (mCSPC).

Approximately 40,000 cases of mCSPC are diagnosed annually in the United States. It is a form of prostate cancer that has spread to other parts of the body, but still responds to androgen deprivation therapy (ADT). ADT is a current standard of care aimed at lowering the level of testosterone in the body. Lower testosterone levels can help control the spread of prostate cancer.

In a clinical trial, Erleada plus ADT significantly extended overall survival (OS) compared to placebo plus ADT and reduced the risk of death by 33%. The two-year OS rates after a median follow-up of 22.7 months were 84% percent for Erleada plus ADT versus 78% for placebo plus ADT. Erleada plus ADT also significantly improved radiographic progression-free survival (rPFS) compared to placebo plus ADT, lowering the risk of radiographic progression by 52%.

Recommended dosing is 240mg (four 60mg tablets) taken by mouth once daily. Tablets should be swallowed whole, and can be taken with or without food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently, or should have undergone a bilateral orchiectomy.

Erleada first received FDA approval in 2018, and is also approved to treat non-metastatic castration-resistant prostate cancer.

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