J&J’s Janssen releases new dosing strength for Erleada

Johnson & Johnson's Janssen is offering an additional tablet strength of Erleada (apalutamide). The introduction of a 240 mg tablet provides the first-and-only option for a once-daily, single-tablet Androgen Receptor Inhibitor approved for the treatment of patients with non-metastatic castration-resistant prostate cancer and the treatment of patients with metastatic castration-sensitive prostate cancer, the company said.

With two strengths available, healthcare professionals will have the flexibility to prescribe the approved 240 mg once-daily dose of Erleda in either one 240 mg tablet or four 60 mg tablets. The single-tablet option may be preferable for patients in need of reducing their total number of daily pills, the company said.

Erleada remains the only ARI with labeling to include approved alternate administration methods for patients who have difficulty swallowing tablets whole. The 60 mg tablets continue to have an approved option for dispersing with applesauce, while the 240 mg tablet is approved for dispersing in orange juice, water or applesauce. The 240 mg tablet may also be administered through a feeding tube.

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“Each person and their cancer are unique and, as such, there is no one-size-fits-all approach to treatment,” said Luca Dezzani, vice president of medical affairs, solid tumor at Janssen Scientific Affairs. "The availability of 240 mg and 60 mg strength options of Erleada demonstrates Janssen’s commitment to prostate cancer patients and provides prescribers flexibility in dosing and methods of administration to fit each patient’s unique needs.”

Both tablet strengths are available via prescription through existing specialty pharmacy networks.

Erleada received FDA approval for nmCRPC in February 2018 and mCSPC in September 2019. 

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